CE marking for medical devices

As we all know CE Marking stands for CE stands for Conformité Européenne (French), which means European conformity. CE Marking focuses on Health and Safety & Environmental protection standard. The CE mark is compulsory conformity marking for specific products traded in the European Economic Area (EEA) since 1985. The CE Marking gives you intelligence to sell your product in the EU, Norway, Iceland, and Liechtenstein. The CE marking wipes out your need for interest in many competing jurisdictional laws covering your products. CE marking converts another level of safety for customers and other end-users, which lower damage claims and insurance premiums.

You must obtain CE marking on your medical devices which will give you the right to sell your medical devices in European countries (EU), CE marking determines that your medical device fulfills with the appropriate EU organizations and allows the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for managing regulatory assent and guarding CE Marking for your product, although of whether you outsource any or all components of your manufacturing operation. A manufacturer is described as a person who is able to design and manufacturing a product with the intention of placing it in on the market under their personal name or brand. Even a person really manufactures, designs, packs, assembles, labels or processes a product themselves, or they authorize out any or all of certain duties, does not imply in concerns to CE marking. The manufacturer has the responsibility to assure that the product and design are made in agreement with the relevant act. They must also pick up the expected professional documentation and assure those relevant assessment methods are carried out.

CE Marking logo affixed on the medical device shows the device fulfills the quality specifications and coordinated standards. Medical Device Regulation EU MDR Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are the two new regulations on the medical device.

Also, check ——>> CE marking certification in Sri Lanka

How to obtain CE marking for your medical device

CE is not a quality mark, but an understanding with EU Directives needs you to meet the appropriate standards of performance, quality, safety, and efficacy for your product type. However, the basic process follows these steps:

1. Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC).
2. Determine the classification of your device. See our chart.
3. Classify all the EU directives and standard for the product applicant of CE marking.
4. Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
5. Prepare a CE Marking Technical File or a Design Dossier.
6. Perform the conformity assessment according to relevant EU requirements of the directives.
7. Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR).
8. Take necessary measures to make corrections of any divergence in the marking process.
9. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
10. Attest the CE marking of the product.
11. Have your QMS and Technical File/Design Dossier audited by a Notified Body unless your device is Class I, is not sterile and has no measuring function.
12. Obtain CE Marking and ISO 13485 certificates from your Notified Body.
13. Arrange all the required documents and certificates.
14. Prepare and sign the EU declaration of Conformity.
15. Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

Also, check ——>> CE marking consultant in Sri Lanka

To make the CE Marking certification process more simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• CE Marking & how to get Certified

NOTE: The process of the medical device will be changed when Europe’s new Medical Device Regulation (MDR 2017/745) comes into force in May 2020.

Why Companies Obtain ISO Certification

You must be wondering whether its worth to obtain ISO certifications for your Company, your Organization, and your business According to dozens of studies, the answer is yes!

Nowadays every company wants to obtain ISO Certification to continuously satisfying customers, management and employees, also to reducing cost and to improve the process. Businesses, irrespective of their size, a business model can get ISO Certification. There are numerous benefits of getting ISO certificate for companies and that is why almost every company thinks they must have ISO Certificate.

Now first you have to understand what is ISO. ISO Standards are a series of the framework that assists you to maintain/run your business successfully/smoothly. ISO certification is verification from an outsider, for example, ourselves, that you comply with an ISO standard. ISO certification gives your association believability. When any company or organizations get certified with ISO it means that there product and services meet the international quality standard. The ISO certification is a lawful or contractual requirement. ISO certification standards are a series of structures that help you to run your business productively. ISO Certificate is evidence from the third party, such as individually, that you follow with an ISO management standard. Customers and stakeholders also start trusting you more. it will also prepare yourself systematically in advanced to handle any critical situation occur in business. Certification adds the reliability of international growth, against other companies that do not express such third-party approvals.

Also, check ——>> ISO Certification in Saudi Arabia

There are thousands of ISO Certifications are there like most popular ISO 9001, ISO 14001, ISO 27001, etc. Now the company needs to understand which certificate they need. if the organization is about the education they can Obtain ISO 29990, if an organization is in the IT field then they can get ISO 27001. ISO 9001 Certification can be obtained by any company irrespective of its size and shape. Obtaining ISO Certification from genuine ISO Certification Company or from ISO Certification Consultant is very important. There are a lot of fraud companies in the market who provide duplicate certification at very cheap prices. And sometimes big companies didn't do enough research about that certification providers company and end up getting a duplicate certificate. So before hiring any consultant or company to obtain ISO certification, understand their knowledge and how they work and tell them to show their previous work.

Benefits by obtaining ISO Certification

• Increased Credibility and Recognition.
• ISO Certification Helps you become more productive.
• Consumer safety and satisfaction.
• Improving system and process efficiency.
• Improve revenues.
• Empowered Employees.
• Boost your ROI (Return On Investment).
• Opens doors to new markets.
• Applies to all sizes.
• Improved participation of employees.
• Suppliers become more like partners.
• Assures that an organization’s information is secure.
• Makes a strong relationship with your supplier.
• Makes an image as an authority on the quality management process.
• Better perception of your company.

How To Get ISO Certified

The ISO Certification did not certify the organization by itself to get ISO Certification you can contact the third-party that will audit your organization and they will decide that your products processes and services fulfill the ISO Criteria or not. The cost of obtaining ISO certification depends on the size of your company and the Standard you choose. ISO is suitable to all big small suppliers, manufacturers, Enterprises, retailer’s food chain all types of business and any organization.

Also, check ——>> ISO Consultant In Saudi Arabia

To make the ISO certification process more simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• ISO Plan & how to get Certified

CE Marking & Certification

CE Marking is a kind of mark which relates to Health and Safety & Environmental protection standard Sold In European Economic Area (EEA), you can also find CE mark outside the European Economic Area (EEA) there is a lot of product which requires CE Mark. CE marking also called as a passport to Europe. With CE marking you can sell your product in European countries, which describe your product is safe and qualified to circulate in European markets. Not all product sold in European union needs CE Marking in order to get access to EU Market. Only products within the field of application of one or more of selected groups of European union technical regulations must be CE Marked. The product that is not covered by CE Legislation is not allotted the bear the CE Marking.

CE Marking is not owned by the CE Company or Organization equivalent to UL or CSA. Such a single organization that publishes standard and certifies product does not exist of CE but if not that then what is CE Marking? The CE Marking is a Conformity marking Consisting of these letters CE. CE is an outline for Conformity European. By affixing the CE Marking to the product the manufacturers will indicate he or she has assessed its conformity with EU health safety and environmental protection legislation and confirms the product compliance with relevant requirements. It's the manufacturers' responsibility to verify the product comply before fixing them in the market. Some cases it is required to have the product examined by a designated third-party conformity assessment body.

The CE Mark doesn't describe as Quality Mark. Firstly CE Mark refers to the protection rather than the quality of a product secondly obtaining a quality marking for a product is voluntary whereas CE Marking is compulsory for those products it applies to. The CE marking is not an indication of an origin and thus not mean that the product is produced in Europe.

Also, check ——>> CE marking certification in Mumbai

Benefits Of CE Marking

• Boost your product image in a market.
• Free movement of goods.
• Manages customer satisfaction easily.
• Proof by technical documents of your product.
• Boost your product image in a market.
• The CE marking wipes out your need for concern about many competing jurisdictional regulations covering your products.
• High level of health, safety, and environmental protection.
• The CE Marking gives you intelligence to sell your product in the EU, Norway, Iceland, and Liechtenstein.
• Increase the sale opportunity in the market.
• Convert another level of safety for customers and other end-users, which lower damage claims and insurance premiums.

Steps To Obtain CE Marking

1. Identify the EU conditions for your product.
2. Check whether your product reaches the particular requirements.
3. Classify all the EU directives and standard for the product applicant of CE marking.
4. Check whether your product needs to be experimented by a Notified Body.
5. Determine if you need third-party assessment.
6. Perform the conformity assessment according to relevant EU requirements of the directives.
7. Arrange all the required documents and certificates.
8. Test your product.
9. Assess product conformity.
10. Compile the technical dossier.
11. Create and maintain technical documentation.
12. Prepare and sign the EU declaration of Compliance.
13. Attest the CE marking of the product.
14. Affix the CE marking and draft a declaration of conformity.
15. Declaration of Conformity & affixing the CE mark.

Which Countries Required CE Marking

1. Austria
2. Belgium
3. Bulgaria
4. Croatia
5. Cyprus
6. Czech Republic
7. Denmark
8. Estonia
9. Finland
10. France
11. Germany
12. Greece
13. Hungary
14. Iceland
15. Ireland
16. Italy
17. Latvia
18. Liechtenstein
19. Lithuania
20. Luxembourg
21. Malta
22. Netherlands
23. Norway
24. Poland
25. Portugal
26. Romania
27. Slovakia
28. Spain
29. Sweden
30. Switzerland
31. Turkey
32. United Kingdom

Also, check ——>> CE marking consultant in Mumbai

How To Get CE Marking

Get CE Marking on the product to grow your business to the next level, to make an image of your product and It also increases customer trust level towards the product. To make the CE Marking process simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• CE Marking Plan & how to get Certified

Top 5 Most Important ISO Standards

ISO is everywhere, ISO is an independent non-governmental organization and the world's largest developer of international standards. International standards make things work. They give world-class specifications for your system, services, and products to ensure quality, safety, and efficiency. They are helpful in promoting international trade. There are many more different ISO standards and sometimes it's difficult to understand which one is the most important and suitable standard for your organization or business. Some standards are universal and can be applied by to any organization whether it's small or big. ISO can be applied by any Companies of all sizes big-small and in all industries such as enterprises, retailers, manufacturers, suppliers, packagers, processors, growers, transporters, planning, production, supply, distribution, storage, installation, controlling, monitoring, maintain and even retailers and restaurants.

If you are not ISO certified in any standard and If you looking for ISO Certification, Here are the top 5 most Important ISO standards currently in place:

1. ISO 9001

ISO 9001 is the most important and popular standard. ISO 9001 Is based on the Quality Management System (QMS) ISO 9001:2015 comes with Constant improvement that ensures your consumers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. ISO 9001 will help your organization to improve the quality process and performance of your product & services. ISO 9001 gives you the capability to stand out with your competitors & immediate growth in Profitable margin.

Benefits Of Being ISO 9001 Certified

• Reduce Waste and Improve Efficiency
• Helps to reduce your costs.
• Improves your quality and services.
• makes a strong relationship with your supplier.
• Increases income and financial performance.
• Boost staff performance and overall productivity.

Also, check ——>> ISO Consultant in Sri Lanka

2. ISO 22000

The ISO 22000 was announced in 2005 by the International Organization for Standardization. ISO 22000:2018 focuses on Food Safety Management System (FSMS). It can apply to any organization of a food chain system.
By obtaining an ISO 22000 certificate you can show your customer that your company has a food safety management system certified. Your food is harmless for health, your food ingredients, and food packaging which supply from a supplier are protected. ISO 22000 has been compared with ISO 9001 in order to enhance the unity of the two standards. The ISO 22000 Certificate instructs correctly what is important to be in a Food Safety Management System. That makes assured the food is stored protected in the entire course food supply chain, right up until when the food is eaten.

Benefits Of Being ISO 22000 Certified

• Gives the capability to enhance your food chain process.
• Engage customers and make a successful organization.
• Protect food safety from hazardous.
• Legally upgrade your documentation.
• Keeps food safety in well mannered during an emergency.
• Makes a better relationship between shareholders and customers.
• Promotes international trade.
• Promote your documentation legally.
• Boost possible economic growth and development.
• Enhance your business globally and increase profit.
• Improved business opportunities.

3. ISO 14001

ISO 14001 was first announced in 1996 by the International Organization for Standardization. ISO 14001:2015 based on the Environmental Management System (EMS). An environmental management system helps organizations manage, control, recognize, and monitor,  their environmental problems in a “comprehensive” manner. ISO 14001 helps to regulate, monitor and develop environmental management. ISO 14001:2015 describes the criteria as the environmental management system. Any company can apply this certificate.

Benefits Of Being ISO 14001 Certified

• Manages environmental risks.
• Saves your cost in waste by recycling and consumption.
• Expands employee involvement while working on an ECO-friendly organization.
• Stakeholder’s confidence is gained.
• increase leadership engagement and involvement of employees.
• Environmental performance of suppliers is improved.
• Decreases waste.

4. ISO 27001

The ISO 27001 was announced in 1995 by BSI Group, ISO 27001 relates to Information Security Management System (ISMS). Applying this family standard will help you to enhance security and protect the assets, the organization maintains the safety of assets such as intellectual property, commercial information, employee details or information entrusted to you by third parties.

Benefits Of Being ISO 14001 Certified

• Preserves assets of your company.
• Protects the goodwill and security of your company.
• A contentious benefit protecting other companies.
• Catalogs maintain and decrease the risks.
• A lower expense due to risk evaluation.
• Divine risks in the company.
• Provides secure exchange of the data.
• Built maintenance and handle programs in the company.

5. ISO 50001

The ISO 50001 focuses on Energy Management System (EnMS). It was published in June 2011 by the International Organization for Standardization, ISO 50001 Certification defines the requirements for maintaining, establishing, implementing and improving the energy management system, whose goal is to helps the organization in energy performance, energy security, energy efficiency, and energy consumption. ISO 50001 Standard also focus to reduce the energy use, energy cost and their greenhouse gas emissions of the organization.

Benefits Of Being ISO 50001 Certified

• Reduce energy usage cost.
• Allows the organizations to maintain their energy consumption, which reduces energy bills by increasing company savings.
• Helps in controlling greenhouse gases.
• Continually improve in energy management.
• Avoid energy hazards.
• Allows every employee to be aware of their role in Energy Management.
• Improves operational performance and cost reductions in all section.
• The presence of a healthy and safe environment.

Also, check ——>> ISO Certification in Sri Lanka

How To Get ISO Certified

To make the ISO Certification process simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• ISO 13485 Plan & how to get Certified

It’s also important to keep an eye out for updates because the standards are constantly being changed in order to account for government laws and regulations, social attitudes, and technology.

What Is ISO Certification

The ISO stands for International Organization for Standardization ISO was published on 23 February 1947. ISO certification relates to the documentation of the management system by the method of the documentation Meets the Quality Objectives, Quality Manual, Job Descriptions, and Work Instructions and manages records of various activities. ISO Certification is a useful tool to add up the probability, by describing that your product and services reach the expectation of your consumers. for some industries, the ISO certification is a lawful or contractual requirement. ISO certification standards are a series of structures that help you to run your business productively. ISO Certificate is evidence from the third party, such as individually, that you follow with an ISO management standard. By Obtaining ISO Certification for your organization ISO certification provides better credibility, customer satisfaction, motivation, reduce your costs, an ability to gain employees and stakeholders trust, Improvement in quality and services and much more. 

The ISO currently issues more than 21,000 standards, in regions ranging such as quality management, occupational health, and safety, and food safety management, Energy management system and much more these standards provide specifications, guidelines, requirements, or components that can be used frequently to assure that products, materials, processes, and services are fit for their plan.

10 Reasons To Obtain ISO Certification For your Organization

1. Improved Processes
2. Better Decision-Making
3. Support for Other Industry-Specific Standards
4. Better Credibility and Improved Perception
5. More Revenue and Profit
6. Reduced Costs
7. Meets Requirements for Government Contracts
8. No Need to Reinvent the Wheel
9. Smoother Ordering and Customer Interaction
10. Greater Customer Satisfaction

Also, check ——>> ISO Consultant in Mumbai

Benefits Of ISO Certification

To reassure your customers that your organization follows the greatest quality standards. Here are some Benefits.

• Save time and money by identifying and solving recurring problems.
• Conveys a positive message to employees and your customers.
• Improving system and process efficiency.
• ISO Certification Helps companies manage risks that could have a negative effect on their performance.
• Makes an image as an authority on the quality management process.
• Boost your ROI (Return On Investment).
• Better perception of your company.
• Improved participation of employees.
• Suppliers become more like partners.
• Assures that an organization’s information is secure.
• Makes a strong relationship with your supplier.
• Increasing customer satisfaction.
• Being more competitive when tendering for contracts.
• Increases income and financial performance.
• Getting more value out of all resources.
• Boosting your credibility in the eyes of your customers.

How to Get ISO Certified

The ISO Certification did not certify the organization by itself to get ISO Certification you can contact the third-party that will audit your organization and they will decide that your products processes and services fulfill the ISO Criteria or not. The cost of obtaining ISO certification depends on the size of your company and the Standard you choose. ISO is suitable to all big small suppliers, manufacturers, Enterprises, retailers food chain all types of business and any organization.
To make the ISO certification process more simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• ISO Plan & how to get Certified

Also, check ——>> ISO Certification in Mumbai

Once your organization has become ISO certified, you can now own the benefits of ISO certification, including Satisfied customers, increased profits, and a better reputation.

What Is ISO 13485 Certification

ISO 13485 stands for Medical devices -- Quality management systems Requirements for regulative purposes is an International Organization for Standardization. ISO 13485 was first announced in 1996 and the current standard was published on 1 March 2016. The latest version has a higher accent on risk management and risk-based decision making, as well as differences related to the enhanced regulatory requirements for companies in the supply chain.

ISO 13485 describes the specifications for a complete quality management system for the design and manufacture of medical devices and the organizations involved in the medical device industry. ISO 13485:2016 can be applied by external and internal parties, such as certification bodies, to support them including their auditing manners. The medical profession is observing continuous improvement in its technologies and equipment. It is also essential for the world to ensure safety measures for it.

Benefits Of ISO 13485

• Improve customer satisfaction
• ISO 13485 allows the establishment of the Quality management system in medical device production, life-cycle process, and maintenance.
• Improve the process of production and maintenance of medical devices.
• Enhances the effectiveness of medical devices
• Improve your processes
• Ensures safety in medical devices.
• Reduces operational cost.
• Improve decision-making.
• Continuous Development in medical devices
• Better employee engagement
• Natural trust in stakeholders and consumers
• Validate customer fulfillment and well-being.
• Encouragement of staff and employee training in medical service providers.
• Improve your company’s credibility and image
• Create a culture of continual improvement

Also, check ——>> ISO 13485 Certification In Saudi Arabia

Requirements Of ISO 13485

ISO 13485:2016 defines requirements for a quality management system where an organization needs to demonstrate its capacity to provide medical devices and similar services that consistently meet consumer and managerial requirements.

• Define adequate quality of design and development plan for medical devices.
• Identification of Quality management process in medical device production and further process.
• Consider customer’s requirements throughout the process.
• Production of sterile medical devices.
• Proper maintenance, control, and repair of medical devices.
• Review the quality of design and development in medical devices.
• Meet documentation requirements fundamental to ISO 13485.
• Safe distribution of medical devices.
• An internal audit of the organization.

Who Can Apply ISO 13485?

ISO 13485 can be implemented by any size of medical co-operation provider during the life-cycle of the device. It is entitled in every stage of device life, from planning, production, supply, distribution, storage, installation, controlling, monitoring, maintain and even for post-production.
It is currently applied by the organization in 21 countries. ISO has adopted a process plan which serves the PDCA act (Plan – Do – Check – Act) cycle which begins in a drive for continued fulfillment in the process of the organization. The Organizations connected to one or various steps of a Medical Device Life-cycle or a Supplier or other External Parties giving such organizations with products for example.

Organizations involved in one or more stages of the medical device life-cycle	Suppliers or External Parties who provide products to such Organizations
·         Design and Development	·         Raw materials
·         Production	·         Components
·         Storage	·         Sub-assemblies
·         Distribution	·         Medical devices
·         Installation	·         Sterilization services
·         Servicing	·         Calibration services
	·         Distribution services
	·         Maintenance services

How To Get ISO 13485

6 steps to achieve ISO 13485:2016 certification

• Planning the quality system
• Meeting regulatory requirements
• Implementing design controls
• Documents, records, and training
• Management processes
• The Certification audit

To make the ISO 13485 Certification process simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• ISO 13485 Plan & how to get Certified