MEDICAL DEVICES
Design and set up of manufacturing sites and virtual manufacturing for all classifications of Medical Devices, including software-based devices
Validation and Design Verification engineering and consultancy
Preparation for Notified Body & Competent Authority audits and inspections
Performance of worldwide audits and mock inspections in line with global regulatory requirements and standards, eg. ISO, EMA, MHRA, MDSAP, ANVISA, TGA
Preparation, authoring and submission of technical files and design history files for global Medical Device launches in line with industry requirements, including Medical Device Regulation (EU) MDR 2017/745, FDA 510k and In-Vitro Diagnostic Regulation IVDR (EU) 2017/746
Quality Management System implementation and remediation in line with industry standards ISO 13485, 21 CFR part 820, MDSAP, ISO 14971, IEC 62304.
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