Value beyond compliance.

Experts in regulatory compliance for Medical Devices and Combination Products (MDCP) and product security

We work with global organizations to design and implement cross-divisional strategic and compliance projects

Regulatory consulting and compliance strategy for MDCP

Design, planning and execution of compliance strategies for EU MDR,  including Article 117 Notified Body Opinions.

Packaging design, anti-counterfeiting  and engineering

Packaging engineering and design of MDCP in line with Design Controls, regulatory and user requirements.

Data & Digital

IT project management, consulting on data governance and strategy, independent data privacy and information security reviews and audits.

Management team

Founded in 2012, we are young and dynamic international team with a clear mission: ensure patient safety and business continuity for our clients.

Carsten Muller

Carsten Ph. Müller

Partner and Head of Data & Digital

Carsten specializes in information security auditing, IT systems and product identification and traceability to ensure regulatory compliance and correct handling of critical business data.

Juan Martín Carriquiry

Juan Martín Carriquiry

Partner and Head of MDCP

Juan specializes on end-to-end regulatory compliance projects for medical devices and combination products (EU MDR, EU/US UDI).

“I had the opportunity to work with Beyond Conception on the implementation of the new MDR and UDI requirements. Beyond Conception provided exceptional support. Not only their exceeding expertise on the MDR requirements but also their efficient project management skills were instrumental in setting up and guiding workstreams to meet the company's goals."

Dr. Uwe Goßlar | Senior Consultant, Granzer Regulatory Consulting & Services

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