I will create a technical documentation for your medical device

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lucas_greulich
L
lucas_greulich
Lucas G
create a technical documentation for your medical device
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create a technical documentation for your medical device

About this gig

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.

Get to know Lucas G

Lucas G
5.0(3)
  • FromGermany
  • Member sinceDec 2024
  • Avg. response time3 hours
  • Last delivery3 weeks

  • Languages

    English, German
"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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