Medical devices, GxP, MDR, EN 62304 — engineering serving health.
Pharmaceutical and medical device engineering: MD design, GxP qualification, MDR / EN 62304 compliance. Laboratories, MD manufacturers, CDMOs.
Standards we master
The healthcare sector combines two distinct but converging regulatory worlds: pharmaceuticals (GxP, ANSM, EMA) and medical devices (MDR 2017/745, EN 62304, IEC 60601). In both cases, traceability is total, documentation outweighs the product, and any deviation can block market launch. FAWI Technologies operates with this dual rigor: qualification of pharmaceutical equipment per GMP, design and compliance of software (SaMD) or hardware medical devices, MDR file support. Our engineers understand that in health, work is never finished — it is validated, documented, audited.
Six concrete technical capabilities mobilized for your projects.
Class I to III MD design — complete MDR 2017/745, EN 62304, IEC 60601, ISO 14971 support.
Pharmaceutical equipment qualification (DQ/IQ/OQ/PQ), process validation, GMP Annex 11.
SaMD development: architecture, software qualification, EN 62304 lifecycle management.
Design and IVDR 2017/746 regulation compliance support for IVD devices.
Pharma process engineering: bioreactors, formulation, aseptic packaging, cleanrooms.
Connected MD security, FDA and MDR cyber requirements compliance, vulnerability management.
Our engineers understand both worlds: GxP for pharma and MDR for medical devices.
Proven FAWI templates and processes for MDR technical files and GxP qualification production.
Every requirement, test, deviation is tracked. Preparation for ANSM, FDA or Notified Body audits.
For the Pharmaceutical & Healthcare sector, we combine these technical engineering domains.
High-precision electronic boards and medical devices.
Industrial software, web platforms and embedded systems.
Industrial AI serving your performance.
Energy efficiency and sustainable industrial systems.
No public offer at the moment, but our Pharmaceutical & Healthcare engineers are on active missions. Subscribe to our TalentPulse to receive our next opportunities in this sector — before they go public.
What is happening in your sector — selected by our engineers.
Pressure on European Notified Bodies leads to particularly long MDR certification timelines for Class IIb and III devices. Manufacturers anticipate by structuring their technical files from the design phase.
European and American agencies converge on the evaluation framework for medical software devices integrating AI. Requirements on training data quality, traceability and continuous learning are becoming clearer.
The FDA now requires a complete cybersecurity file for connected MD submissions. SBOM, vulnerability management and update plans have become mandatory. European manufacturers targeting the US market must align.
Tell us about your project. Our Pharmaceutical & Healthcare engineers will be in touch within 24 hours.
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FAWI Technologies · Île-de-France
