Your quality management system

Your quality management system

Most regulatory authorities require that medical device manufacturers have the Quality Management System (QMS) in place. QMS is a set of policies, processes and procedures needed for planning and execution in the core business area of an organization. The Quality Management System of a medical device company shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with regulations of their target markets.

Regulatory authorities of different countries carry out inspections of manufacturers' Quality Management Systems to determine whether QMS is compliant with quality regulations applicable to medical device companies. Manufacturers located in other countries but selling their devices on a particular market are also subject to QMS inspections.

Most regulatory authorities require that medical device manufacturers have the Quality Management System (QMS) in place. QMS is a set of policies, processes and procedures needed for planning and execution in the core business area of an organization. The Quality Management System of a medical device company shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with regulations of their target markets.

Regulatory authorities of different countries carry out inspections of manufacturers' Quality Management Systems to determine whether QMS is compliant with quality regulations applicable to medical device companies. Manufacturers located in other countries but selling their devices on a particular market are also subject to QMS inspections.

QUALITY SYSTEM REQUIREMENTS

The quality system provisions of the European Union are laid down in article 10 and Annex IX of Regulation EC 2017/745 (in case of in vitro diagnostic devices Regulation EC 2017/746).

In the USA quality systems are regulated by the Code of Federal Regulation section 21 CFR Part 820. Besides, the USA is a member of the MDSAP program allowing a harmonized QMS certification for several countries - USA, Canada, Brazil, Japan, Australia, partly Argentina and South Korea.

In Brazil Resolutions RDC 59/00 and RDC 25/2009 are applicable to manufacturers' QMS. Like the USA, Brazil is a part of the MDSAP program with one QMS certificate for several countries.

According to ANMAT Disposition 3266-2002 in Argentina medical device manufacturers must conform to Argentinian Good Manufacturing Practice (GMP). MDSAP certificates are also recognized by ANMAT.

Mexico's COFEPRIS accepts Quality Management Systems that comply with international harmonized standards and quality systems recognized by the EU, USA and some other countries.

QUALITY SYSTEM REQUIREMENTS

The quality system provisions of the European Union are laid down in article 10 and Annex IX of Regulation EC 2017/745 (in case of in vitro diagnostic devices Regulation EC 2017/746).

In the USA quality systems are regulated by the Code of Federal Regulation section 21 CFR Part 820. Besides, the USA is a member of the MDSAP program allowing a harmonized QMS certification for several countries - USA, Canada, Brazil, Japan, Australia, partly Argentina and South Korea.

In Brazil Resolutions RDC 59/00 and RDC 25/2009 are applicable to manufacturers' QMS. Like the USA, Brazil is a part of the MDSAP program with one QMS certificate for several countries.

According to ANMAT Disposition 3266-2002 in Argentina medical device manufacturers must conform to Argentinian Good Manufacturing Practice (GMP). MDSAP certificates are also recognized by ANMAT.

Mexico's COFEPRIS accepts Quality Management Systems that comply with international harmonized standards and quality systems recognized by the EU, USA and some other countries.

  • Quality Management System compliance can be reached using harmonized standards, one of which is ISO 13485. However, you should bear in mind that not all regulatory authorities recognize ISO 13485 certificates. For instance FDA does not. The American regulatory agency has its own standard 21 CFR Part 820, and companies placing their medical devices on the American market have to conform to this standard. Additionally, being a member of MDSAP program FDA recognizes MDSAP quality system certificates. So if you have an ISO 13485-compliant Quality Management System and want to sell your devices on the American market, you need to tweak your QMS to make it conform to the US requirements.
  • Brazilian and Argentinian quality management standards are similar to the US FDA 21 CFR Part 820. For that reason, if your quality system conforms to the FDA quality requirements, it will be easy to achieve compliance with ANVISA and ANMAT standards. A good option here might be MDSAP certification.
  • Quality Management System compliance can be reached using harmonized standards, one of which is ISO 13485. However, you should bear in mind that not all regulatory authorities recognize ISO 13485 certificates. For instance FDA does not. The American regulatory agency has its own standard 21 CFR Part 820, and companies placing their medical devices on the American market have to conform to this standard. Additionally, being a member of MDSAP program FDA recognizes MDSAP quality system certificates. So if you have an ISO 13485-compliant Quality Management System and want to sell your devices on the American market, you need to tweak your QMS to make it conform to the US requirements.
  • Brazilian and Argentinian quality management standards are similar to the US FDA 21 CFR Part 820. For that reason, if your quality system conforms to the FDA quality requirements, it will be easy to achieve compliance with ANVISA and ANMAT standards. A good option here might be MDSAP certification.

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ISO 13485

International quality management standard

ISO 13485 is an International Organization for Standardization standard that represents the provisions for a comprehensive Quality Management System for the design and manufacture of medical devices. The current ISO 13485 edition ISO 13485:2016 (3-rd edition).

ISO 13485 is not binding. However, it is recomended to acieve ISO 13485-compliance because a number of countries prefer ISO 13485-certified quality systems. In some cases low-risk device manufacturers are exception. They can use QMS based on their internal standards.

In particular, ISO 13485 certification is recommended if the target market of a company is the European Union. ISO 13485 compliance is not a binding requirement in the EU, but de facto a medical device company without an ISO 13485 certificate has vague chances of success in Europe. Besides, in terms of quality systems European Regulations EC 2017/745 and EC 2017/746 are harmonized with ISO 13485. For that reason, creating a Quality Management System that complies with this standard is a logical step for someone placing their medical devices on the European Market.

It is important to remember that not all regulatory agencies accept ISO 13485 certificates. An example of an agency that does not is FDA. In the USA quality system provisions are set out in the 21 CFR 820 standard that was created many years before ISO 13485 and differs from it.

If you consider several medical device markets to commercialize your devices it is recommended to implement a quality system that is adjustable to both ISO 13485 and the national standards of your strategic markets.

We are quality management experts. MDRC can help you implement a Quality Management System at your company that complies with harmonized standards, such as ISO 13485 and MDSAP, and the national regulations. If you have a QMS in place we can adjust it to make it conform to the regulatory requirements of your markets.

ISO 13485 is an International Organization for Standardization standard that represents the provisions for a comprehensive Quality Management System for the design and manufacture of medical devices. The current ISO 13485 edition ISO 13485:2016 (3-rd edition).

ISO 13485 is not binding. However, it is recomended to acieve ISO 13485-compliance because a number of countries prefer ISO 13485-certified quality systems. In some cases low-risk device manufacturers are exception. They can use QMS based on their internal standards.

In particular, ISO 13485 certification is recommended if the target market of a company is the European Union. ISO 13485 compliance is not a binding requirement in the EU, but de facto a medical device company without an ISO 13485 certificate has vague chances of success in Europe. Besides, in terms of quality systems European Regulations EC 2017/745 and EC 2017/746 are harmonized with ISO 13485. For that reason, creating a Quality Management System that complies with this standard is a logical step for someone placing their medical devices on the European Market.

It is important to remember that not all regulatory agencies accept ISO 13485 certificates. An example of an agency that does not is FDA. In the USA quality system provisions are set out in the 21 CFR 820 standard that was created many years before ISO 13485 and differs from it.

If you consider several medical device markets to commercialize your devices it is recommended to implement a quality system that is adjustable to both ISO 13485 and the national standards of your strategic markets.

We are quality management experts. MDRC can help you implement a Quality Management System at your company that complies with harmonized standards, such as ISO 13485 and MDSAP, and the national regulations. If you have a QMS in place we can adjust it to make it conform to the regulatory requirements of your markets.

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