Setting up a Quality Management System (QMS), for a medical device, requires a series of predefined controls that supervise all aspects of a product.
These aspects generally include the following (among others), although requirements may change under each governing law and applicable standards of each market:
Medical devices used in differed locations worldwide must comply with several standards, in accordance to their business goals as well as national guidance, for example:
Drug-Device combination products must comply with several standards, in accordance to their business goals as well as national guidance, for example:
QMS requirements worldwide are rather similar in nature as they mostly rely on either the European ISO 13485 or the US 21 CFR Part 820
Manufacturers can streamline their efforts by endorsing a single, harmonized quality management system that meets the requirements of all markets in which the manufacturer operates.
A QMS construction can be approached in stages of the product lifecycle:
GEMARMED’s experts can help to plan and quickly and cost-effectively implement quality systems that comply with various regulatory directives. Whether you represent an established company or a start-up taking its first steps, GEMARMED will ensure that a well-planned quality system is in place that meets all relevant regulatory requirements. Our solutions are flexible and tailored to your needs, and we are able to offer as much or as little support as you may require.