When it comes to manufacturing medical devices, there's an important factor in choosing a Contract Manufacturer: ISO 13485 certification. While liability for the design failure would rest with the design owner, failures due to wrong material, negligence, etc. would rest on the Contract Manufacturer. Due to such associated risks, companies who plan on manufacturing Medical Devices through a CM must make sure that the CM holds a valid ISO 13485 certification.
Bringing a new Medical Device to the market? How will you tackle the commercialization process? Are you a start-up that has stakeholders and investors on edge pestering when your final product will hit the market? If yes, then you'll benefit from outsourcing your medical equipment to a Contract Manufacturer.
There are many benefits of outsourcing to a Contract Manufacturer and when a company is trying to bring a medical device to market, there's a lot at stake because the medical industry requires additional tests and processes before a Medical Device can be brought to market. We wrote a blog on the extra elements required for Medical Device Development a few months ago, read more on that here, and for this post, we'll highlight the expected benefits medical device companies can expect when outsourcing to an experienced CM.
Recently, I was researching one of our favorite industries, medical device manufacturing, and came across an extremely well-written article with some excellent points that deserved commentary. Being a contract manufacturer for medical device OEMs gives PEKO a particular insight into the industry. Every day, projects come across our desk that can be anywhere from prototype, beta or even full rate production stage in their product commercialization life cycle. Each phase has it's own particularities that only a truly qualified manufacturer can navigate.