Lucas Greulich

Hello, I'm Lucas – a passionate Regulatory Affairs & Quality Manager. My main drive was and is to ensure that meaningful medical devices do not fail due to regulatory hurdles. That's exactly why I started my freelance career: to help manufacturers practically bring their products to market efficiently, safely, and in compliance with regulations.

I bring over 10 years of experience in medical technology – in both start-ups and established companies – and support manufacturers in all phases of regulatory documentation and quality assurance.

My services at a glance:

Creation of technical documentation according to MDR (Class I, Im, IIa)

Development and maintenance of QM systems according to ISO 13485

Creation of risk analyses, clinical evaluations, PMS/PMCF plans

Assumption of the role as external PRRC according to MDR Article 15

Consulting on standards such as IEC 60601-1, IEC 62366,

Implementation of risk-based QM instructions and process optimization

Preparation for audits and authority requests

I work in a structured, fast, and solution-oriented manner – and place great value on clarity and practicality. Open, partnership-based collaboration at eye level is particularly important to me.