Master the requirements of post-market surveillance process from every angle
Benefit from a comprehensive guide and customizable templates (.docx), in compliance with Annex III of MDR 2017/745, featuring pre-written sections, ready-to-use tables, and real-life examples for each section, thanks to our immersive device, the 'HealthGuard BPX-2000.'
Master each step from planning to data collection, analysis, and report writing for your PSUR
Take advantage of a complete document box that covers all the regulatory requirements related to post-market surveillance. Inspired by a custom-made device, you will be immersed completely, enabling you to draw inspiration in drafting your PSUR
« The examples provided in the PSUR are very concrete, facilitating an easy transition from analysis to conclusion. »
« The activity planning table in the PMS plan offers straightforward collection and analysis methods accessible for any organization to implement! »
We've meticulously ensured that no regulatory requirements are overlooked in creating a template that is as compliant as possible with regulations
We complete the MDCG 2022-21 by providing tailored collection methods and in-depth analysis examples for every section. Our PMS box includes replicable analyses for your devices, pre-written conclusions, and offers a comprehensive view from planning through to conclusion.
Though some methods in the technical report are effective, they don't fully align with regulations. Our PMS box comprehensively covers regulatory details.
Leverage our 3+ years of EU MDR 2017/745 audit experience for seamless post-market surveillance compliance, proven in recent audits.
Tailor your post-market surveillance plan your way, leveraging our proven methods
Strategically plan your entire surveillance period with precision in our PMS plan
Implement the right data collection methods tailored to your needs
Optimize your data analysis and undertake the right actions efficiently
Discover the 'HealthGuard BPX-2000', a meticulously designed fictitious medical device by our experts for full immersion and comprehensive understanding. Gain inspiration from a realistic model, adaptable to your or your clients' needs.
This template enables you to:
✅Employ concrete collection and analysis methods to ensure regulatory compliance
✅Access a fully editable Word document (.docx) to streamline your writing process
✅Utilize pre-written paragraphs and tables for each section, saving time and effort
✅Benefit from over 3 years of experience in EU MDR 2017/745 audits
✅Meet all regulatory requirements for post-market surveillance documentation with ease
✅Draw inspiration from a real PMS plan and PSUR to expertly craft your own
We hide nothing, explore examples of what's inside the PMS Box
Plan your entire post-market surveillance and benefit from exclusive annexes guiding you in planning and data collection
Craft your PSUR with our pre-written sections and concrete examples using our device - all you need to do is tailor it to your device!
The offer may evolve based on your feedback and regulatory requirements. Once in your possession, you will receive updates free of charge.
Gain access to our private beta of the EU MDR COMPLIANCE PMS Assistant
We've trained a chatbot with all our knowledge on post-market surveillance to provide you with precise answers. Its responses are based on the MDR 2017/745 regulation and our expertise
💡Our beta version already offers accurate and precise responses. Please note that this access is not part of the PMS box; it is an invitation you will receive upon acquiring the PMS BOX. Also, note that you must be a member of CHAT GPT PLUS to use this assistant.