I will create a technical documentation for your medical device

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lucas_greulich
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Lucas G
Einige Informationen werden in englischer Sprache angezeigt.
create a technical documentation for your medical device
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create a technical documentation for your medical device

Über diesen Service

I will create or review your technical documentation according to EU MDR 2017/745, tailored to your medical device and risk class.

My services include:


GSPR checklist


Risk Management file


Instructions for Use (IFU)


Labelling


PMS and (if needed) PMCF plan


Declaration of Conformity draft



The result will be a complete, audit-ready file that meets MDR requirements for Class IIIa devices.

With over 10 years of experience in regulatory affairs and ISO 13485, I ensure high-quality, customized documentation.

Lerne Lucas G kennen

Lucas G
5,0(3)
  • AusDeutschland
  • Mitglied seitDez. 2024
  • ⌀ Antwortzeit3 Stunden
  • Letzte Lieferung3 Wochen

  • Sprachen

    Deutsch, Englisch
"I offer professional support in the certification and approval of medical devices within and outside the EU. With extensive experience in MDR certifications, product testing, and the creation of technical documentation, I ensure compliance with regulatory requirements. Let me help you navigate the complex certification process and deliver high-quality, compliant documentation tailored to your needs."

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