Quality Management System (QMS) for Medical Devices

One of the first issues a manufacturer of a medical device must decide upon is how he is to guarantee certifiable, transparent and record-based compliance with the regulatory demands of the target market. And, how to pass regulatory audits and inspections with ease.

A Quality Management System (QMS) for medical devices is a structured system of processes and procedures for managing and overseeing many facets of the development process, which are:

  • design; 
  • engineering;
  • manufacturing,
  • risk management;
  • technical quality assurance;
  • supplier management;
  • handling of customer feedback;
  • clinical data gathering;
  • product marking;
  • storage;
  • distribution.

What are the possible forms of QMSs for medical devices?

Development of all medical devices (MD) demands that the manufacturer employs a form of QMS; the latter can be an ad hoc system, perhaps even a partially paper-based or one utilising disconnected IT tools and storage locations. Conversely, it can be a unified QMS software solution. These can, in turn, be classified as general-purpose QMSs and dedicated QMSs.

General-purpose QMSs are not created explicitly for the medical device sector and omit MD-targeted best practices and templates, applicable regulatory standards or built-in domain expertise – but can also be used in other fields. Dedicated QMSs, on the other hand, assist in dealing with MD specific procedures and medical device regulatory issues.

Can you bring a medical device to market effectively without a QMS?

Companies designing making medium-risk (Class II) devices usually cannot bring a product to market effectively without using at least a general-purpose QMS. At the same time, manufacturers of high-risk devices (Class III) sooner or later start employing dedicated QMSs. The latter include integrated closed-loop traceability (CLT) of quality processes, among which are changes, audits, design controls, list of CAPAs (Corrective Actions and Preventive Actions) and customer feedback.

Such systems can enforce documental-process compliance with quality-associated regulations, such as FDA’s 21 CFR Part 820 and ISO 13485:2016, out of the box. Furthermore, these systems are continuously updated to comply with the latest standards and regulations in the medical device industry. Another QMS deliverable that a manufacturer has to take into account is a design history file (DHF) which can be automatically updated and produced on the fly in a dedicated QMS. In contrast, the same procedure may take weeks in an ad hoc system.

Which are the principal international regulations overseeing the medical device QMSs?

The new EU Commission’s Medical Device Regulation (MDR) now also demands an exact technical file structure from a QMS. The principal international regulations that oversee medical device QMSs – and are a de fact condition of product registration – are the ISO 13485 standard (popular in Europe) and US FDA’s Quality System Regulation (QSR).

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