Medical Devices Regulations Consultancy
Medical Equipment Manufacturing
Medical Devices Regulations Consultancy is a company with a focus on regulatory and norm compliance support.
About us
Medical Devices Regulations Consultancy is a company to provide worldwide regulatory and norm compliance advice, expertise and resources in the medical device consulting industry regarding medium & high risk medical devices throughout the lifecycle of the devices, including both the pre-clinical and clinical phases of development and in both pre-market and post-market period.
- Industry
- Medical Equipment Manufacturing
- Company size
- 1 employee
- Headquarters
- Pijnacker
- Type
- Self-Employed
- Founded
- 2023
- Specialties
- Regulatory Strategy, Design History File, Basic safety IEC 60601, Active Implantable ISO 14708, Software IEC 62304, Risk Assessment ISO 14971, Failure Mode Effect Analysis, Labeling, Usability IEC 62366, Clinical Investigation ISO 14155, Clinical Evaluation MDCG 2020-13, MDR 2017/745, STED, 510(k) eSTAR, QMS ISO 13485, and Due Diligence
Locations
-
Primary
Get directions
Atalantazoom 18
Pijnacker, NL