Are you missing certain documents to provide complete evidence of the post-market surveillance (PMS), post-market clinical follow-up (PMCF), or post-market performance follow-up (PMPF) that has been performed?
Or are you concerned that your existing documentation may not meet all the required criteria? Have you perhaps already received deviations from your notified body or authority and feel stuck?
No more sweating when audits or reviews are due: We help you create regulatory compliant documents that meet all the expectations of authorities and notified bodies.
We turn the creation of your post-market documents into a sprint so you can impress with quick results and avoid time-consuming corrections of non-conformities.
You benefit from templates that have proven themselves countless times in audits and reviews. That puts you on the safe side and saves you time and money.
Our more than 100 experts are also available to help you with other topics, such as clinical or performance evaluation or risk management.
Our team of experts will support you exactly where you need it and quickly assist you whenever needed:
We create any missing documents, such as the PMS-, PMCF-, or PMPF plan, individual evaluation reports, or the PSUR.
We review the documents you created and provide suggestions for improvement.
Our experts can help you initially set up a functioning PMS or PMCF process or improve your existing one.
Our team is also happy to help you understand how all the required regulatory processes interlock and how you can easily get a routine into your post-market surveillance.
With the Post-Market Radar, the high manual search effort is history. We are taking over the continuous search, filtering, and documentation of relevant data and information on your own and benchmark devices.
Contact us now to find the best form of support for your PMS, PMCF, or PMPF.
Phone
+49 7531 94500 20
Contact Form
We help medical device manufacturers pass the approval, audits, and reviews quickly and safely with legally compliant clinical evaluations.
We help IVD manufacturers and medical laboratories pass the approval, audits, and reviews quickly and safely with legally compliant performance evaluations.
Our team will help you achieve efficient risk management, compliant files, and safe medical and IVD medical devices that can be quickly brought to market.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.
