QMS documentation of Medical Devices.

1. QMS documentation of Medical Devices. Any regulatory system always insists for written instruction for how to carry out any processes and needs written verifiable data in written form. This does not mean that it must be in hard copy mode. Digital mode is also acceptable provided it satisfy control, safety and integrity requirements. One of the biggest advantages of written documentation is that everyone follows the same system and shares the data universally which can be utilised for betterment of patients and users like medical professionals and others. What is needed in QMS for medical device? Detailed list will be very long but let us try to cover essentials of what is described in ISO, US FDA, EU regulatory guidelines. Scope of this blog is that what area are essential to cover and very very essential to cover in that area. Let s take some references which will be essential to refer for this. ISO 13485-2016, US FDA 510k submission guideline, EU MDR guideline replacing old MDD guideline. QMS is nothing but the documented system describing procedures for each process covering design, production, testing, supplier management, risk management, complaint handling, storage, transportation, distribution, product registration, clinical evaluation, data management, Product labelling, CE marking for Europe. Each process is complex based on complexity of the device class. Device of Class 1 will have very less complex requirement as compared to class II and class III where sterility, aseptic processing, are involved hence such system becomes more complex and another system of validation also becomes applicable.Before building system, device class must be known.

2. Let us understand broadly which QMS are essential apart from their own processes. In Production and Process control involving validation, Supplier quality, Complaint handling, Product identification and traceability are essential. We all know that QMS must be dynamic, but it must be governed by change management which involves, design change, Risk assessment and risk control and entire QMS change management itself. Basic starting point for device is design, design control with respect to its input and verified output and ultimately validation are essential to design. No matter whatever best you do to make system, there are bound to be issues, failures, complaints so they need to be attended but also improvement need to be generated from there so comes CAPA management (Corrective and preventive action). This helps eliminating non-compliances thus improving QMS. This improvement need to be verified also. Medical device real test is with user only so Post market surveillance is essential defined system in regulatory. This automatically covers complaint handling, vigilance and compels us to Risk monitoring. All processes are defined with responsibility and authority to approve. However, organisation also need to have defined system of review by top management called management review, periodic verification through internal audit and readiness for external regulatory audit. To manage entire QMS in effective manner organisation needs sufficient resources and they also need to be manged well with processes. Conducive environment also need to be provided to become successful. Its not choice but mandatory that every medical device registration in ever market mush follow QMS. ISO 13485 is followed in Europe, Canada and Australia. (Do not forget newly introduced standard EU MDR)It is not compulsory for Canada, but it is usually followed and accepted. US follows 21 CFR part 820. US must follow ISO 13485 if it exports product outside USA. Other countries have their own requirements, mostly derived from ISO 13485 or US FDA regulation or both. Each country has its own process for controlling and monitoring the registered product like US does periodic inspection. Europe needs CE marking as condition for marketing products in Europe. Europe also has inspection through Notified bodies. In short for all such things QMS is basic requirement.