Ee Bin Liew Good to have. The design firm must take all relevant aspects of 13485, including the establishment of a quality system, incorporated appropriately. Otherwise the clients may be in trouble for lack of design documentation or from a lack of a healthy, functioning quality system. Certification is a cost of course, but it helps to keep the design firm on its toes, and it's also a marketing aid. hope it helps.

Cheers,
Ee Bin

Phil Cashen Ee Bin, Thanks for your feedback. Phil

Not required but good to have. Making life of the clients which must have 13485 much easier (hopefully this translates into "attracting such clients much more"). Even you do not have it, the clients may ask you to do things per 13485 anyway. If you have many medical clients, soon or later different clients' different requirements, each based on the client's own QMS, could mess your system up. I'd rather have my own 13485 and convince the clients to respect my own QMS.

Karen Boyd, ASQ CQA I would say "must have" with respect to actual adherence to ISO 13485 requirements, (not necessarily certification), as well as those government / statutory requirements that may be pertinent to regions of device manufacturing, marketing, and sale (FDA, EU, Health Canada, etc.).
(Likewise, a design firm for a U.S. product could be a "specification developer" and required to register and list with the FDA, for example.)
I would say "good to have" with respect to actual knowledge (along with adherence) to ISO 13485 requirements. If the design firm is considered a "critical" supplier to the medical client, it is possible that the client may require ISO 13485 certification of the design firm.

Phil Cashen Thanks to all of you for your input. We are reviewing our options and your feedback will be most helpful. Phil

Clarisa Tate I believe for a design firm for medical devices, ISO 13485 certification is "not required" (as Cynthia says) but a "must have" (as Karen said) if that makes sense. If used sincerely and effectively, ISO 13485 can elevate you as a company.

From the perspective of a manufacturer, it just makes it so much easier to explain why certain things need to happen a particular way or why certain documents are required or why they are not acceptable "enough". I believe there's been enough suppliers out there who supposedly comply and would probably not pass an audit from a respectable notified body if they ever get ISO 13485 certified. For many, it was painful dealing with these companies.

Also, it will help if there is flexibility in the quality system to allow for client's preferences: from document templates to how specifications are written, drawings are made, etc. Those little things can get you sometimes. Good luck!

I have been developing medical products for almost 30 years as an independent consultant and engineering design and development firm. I do not have ISO 13485 certification for my company. For established companies, I operate under their SOP's for design control, documentation and other areas. Sometimes we go through a documented training for their SOPs. If I have a start-up client, I provide the pertinent SOP's for them to ensure that we operate under a system that meets FDA requirements. I assist many clients with their specification development but they are the specification developer and own the product from the FDA's perspective. Using this approach, I have developed products for a very large European medical device company and for a number of US companies without any problems with the FDA. You do need to operate under SOP's that meet the cGMP design control and other areas, which alleviates the need for ISO 13485. It is certainly not needed for developing products for US companies as the FDA cGMP regulations are the controlling factor.