Starting from the first idea to the clinical evaluation and more

Support in realizing your visions in medical engineering

Legal Basis

European regulations, European directives
Medical Devices Act, Medical Devices Consultant
Product liability, warranty, guarantee

Biocompatibility, Toxicity, Microbiology, Hygiene

ISO 10993 - Biological evaluation of medical devices

Quality Management

ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes

Basic Safety, Electrical Safety of Medical Devices

IEC 60601 - Medical electrical equipment

Medical Software, IT Validation, IT Security

IEC 62304 - Medical device software - Software lifecycle processes
GAMP 5 - Good Automated Manufacturing Practice

Production, Packaging, Transport, Labelling of Medical Devices

Clinical Evaluation, Clinical Trials of Medical Devices

MEDDEV 2.7/1 revision 4 - Clinical Evaluation: a guide for manufacturers and notified bodies
ISO 14155 - Clinical evaluation of medical devices for human subjects - Good clinical practice

Usability of Medical Devices

IEC 62366 - Medical devices - Application of usability engineering to medical devices

Interdisciplinarity

Special needs for a special industry. Profit from our technical and clinical perspective on the development of medical devices.

Network

You need advice and knowledge in clinical or technical niche markets? Our business is located right in the middle of the Medical Valley