Post-Market Surveillance, Post-Market Clinical Follow-up, Post-Market Performance Follow-up
We help you to create post-market documents that are compliant with the regulations and can be submitted right away
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?
Our team of experts will support you exactly where you need it and quickly assist you whenever needed.
Sit back and relax: We will spare you unnecessary stress during the review of your PMS/PMCF documents by authorities and notified bodies
Regulatory safety
No more sweating when audits or reviews are due: We help you to create regulatory compliant documents that meet all the expectations of authorities and notified bodies.
Quick implementation
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.
Valuable templates
You benefit from templates that have proven themselves countless times in audits and reviews. This puts you on the safe side and saves you time and money.
Everything from a single source
Our more than 100 experts are also available to help you with other topics as needed, such as clinical or performance evaluation or risk management.
Fast and reliable support for your post-market activities
- We create any missing documents, such as the PMS-/PMCF-/PMPF plan, individual assessment reports, or the PSUR.
- We review the documents you created and provide suggestions for improvement.
- Our experts can also 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.
Get rid of annoying routine tasks: Automate your Post-Market Surveillance with the Post-Market Radar
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.
Further support services besides post-market documentation
Clinical Evaluation
We help medical device manufacturers to pass approvals, audits, and reviews quickly and safely with legally compliant clinical evaluations.
Performance Evaluation
We help IVD manufacturers to pass approvals, audits, and reviews quickly and safely with legally compliant performance evaluations.
Seminars, and Workshops
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops allow you to talk to experts at eye level.
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