Just have an audit? (actually when aren’t you under audit?) whether it was a customer, Notified Body, or Agency you are bound to have findings. We can work within your CAPA system to remediate findings quickly.

Looking to expand sales into a new regulated territory? We’ve got experience working with all the major worldwide spaces (Except China) to assure your compliance and conformance.

The newly applied Medical Device Regulation (MDR) replacing the Medical Device Directive (MDD) has thrown everything on it’s head. We have navigated several clients through QMS and Technical Dossier update. You are running out of time! We can get you there!

While the industry trend is for big device manufacturers to go vertical or discontinue sale, there is a space that contract manufacturers can occupy profitably and we can guide you there.

We’ve got resources with decades of contract review and negotiation under their belts. We’re in your corner and way less expensive than lawyers. Supplier facing or customer facing we can get all of your agreements to the out basket.

Risk Management is an essential and living part of your organization. ISO 14971:2019 and all of the worlds top regulatory standards require risk management to go well beyond a FMEA and PFMEA. We can help implement practical and productive risk management processes and records for your org.

We have resources in our network to establish and implement appropriate activities for CEP, CER, PSUR, PMCF and baselining state-of-the-art.

If your MDD and FDA (510k) devices are based on predicates, we can help you navigate through literature searches, customer surveys, and if required conducting clinical studies to generate statistically relevant original clinical evidence. We studied MDCG 2020-6 and worked with Notified Bodies and Authorized Representatives to plan and execute contracted clinical studies.