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Medical Device Development
Mechanical Design
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Reverse Engineering – Laser Scanning
3D Tomography Analysis
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Quality & Validation
MDSAP – Medical Device Single Audit Program
Quality System Support
ISO 13485 Auditing Service
SOP – IOP
VMP IQ/OQ/PQ Validation
Clean Room Design and Validation
Regulatory Support
MDR 2017/745
European Authorized Representative Service
CH-REP – SAR Swiss Authorized Representative service
EU PRRC
Technical File Design Dossier
Clinical Evaluation
DHF Design History File
Risk Management Process
ISO 14971:2012 – 2019 Gap Analysis
Design Control Process
Testing
Mechanical Test Fatigue Static
Biological Safety Evaluation
ISO 10993-17 Toxicological Evaluation
Cardiovascular Digital Simulation Model
Electronic IFU (e-IFU)
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