In our Nexus Meets series, we chat to members of our community to learn more about them and who they’d like to work with.

Hi, my name’s Adnan Ashfaq, and I represent Simplimedica. So Simplimedica is a boutique regulatory and quality consultancy business, focused on Medtech. We’ve been operating for the last 15 years nearly. So next year will be actually the 15th anniversary. So we’re looking to do some kind of celebration and maybe we’ll do it here at Nexus.

So Simplimedica specialises in looking after startup medical device companies that looking for CE marking, CE clearance, UKC marking, FDA submissions, basically if they want regulatory clearance. And if they are a medical device, whether that’s digital healthcare, whether it’s a physical medical device, all classifications will basically guide startup businesses from A-Z right through from concept to market.

So basically we are open to having more and more businesses that are startups that are looking for this type of service, which there’s a lot of technicalities, there are lots of legal terms to get to grips with. We’re basically trying to simplify the entire device regulations if there’s such a thing.

So Simplimedica is happy to collaborate with any businesses in the Nexus community, which is basically thinking of developing a medical device, or already developing a medical device. And even if they don’t know they’re developing a medical device, but they might be borderline and they need some advice or guidance because very often what happens is you might have Wellness devices, Wellness apps, especially in software, there can be lots of confusion whether a device actually is a medical device or not. So we basically we need to come at that point where we’re trying to define the device, whether it fits the definition of a medical device and it’s not Wellness. So anyone in the community that we can assist with on that front and then just reach out and speak to us and we’ll see what we can do.