What are some of the common contract manufacturing industry standards for medical devices?

1 ISO 13485

One of the most widely recognized and accepted standards for medical device contract manufacturing is ISO 13485, which specifies the requirements for a quality management system (QMS) for medical device manufacturers and suppliers. ISO 13485 covers aspects such as design, development, production, installation, service, and distribution of medical devices, and aims to ensure consistent quality, safety, and performance. If you are looking for a contract manufacturer for your medical device, you should check if they have ISO 13485 certification, which demonstrates their commitment to meeting the expectations of customers and regulators.

2 FDA 21 CFR Part 820

Another important standard for medical device contract manufacturing is the FDA 21 CFR Part 820, which is the Code of Federal Regulations that governs the quality system regulation (QSR) for medical devices sold in the United States. The QSR sets forth the requirements for design controls, document controls, production and process controls, corrective and preventive actions, and other elements of a QMS for medical device manufacturers and suppliers. The QSR also defines the roles and responsibilities of both the contract manufacturer and the original equipment manufacturer (OEM) in ensuring compliance with the FDA regulations. If you are outsourcing your medical device production to a contract manufacturer, you should make sure that they follow the QSR and have a clear agreement on who is responsible for what.

3 MDR and IVDR

If you are planning to sell your medical device in the European Union (EU), you should also be aware of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which replaced the previous directives in 2020 and 2022, respectively. The MDR and IVDR introduce more stringent requirements for medical device manufacturers and suppliers, such as increased clinical evidence, post-market surveillance, risk management, and traceability. The MDR and IVDR also affect the role and liability of contract manufacturers, who may be considered as legal manufacturers under certain circumstances. Therefore, if you are outsourcing your medical device production to a contract manufacturer, you should ensure that they are familiar with the MDR and IVDR and can help you comply with them.

4 ISO 14971

Another common standard for medical device contract manufacturing is ISO 14971, which provides a framework for managing the risks associated with medical devices throughout their lifecycle. ISO 14971 covers aspects such as risk analysis, risk evaluation, risk control, risk communication, and risk review, and helps medical device manufacturers and suppliers to identify, assess, and mitigate the potential hazards and harms of their products. If you are working with a contract manufacturer for your medical device, you should verify that they have a robust risk management process in place and that they follow the ISO 14971 principles and guidelines.

5 ISO 10993

Finally, one more standard that you should consider for medical device contract manufacturing is ISO 10993, which specifies the requirements for the biological evaluation of medical devices. ISO 10993 covers aspects such as biocompatibility testing, toxicological risk assessment, and clinical data analysis, and helps medical device manufacturers and suppliers to ensure that their products are safe and compatible with the human body. If you are outsourcing your medical device production to a contract manufacturer, you should check that they have the necessary expertise and equipment to perform the ISO 10993 tests and that they can provide you with the relevant documentation and reports.