Swiss MPC · Projets

Études de cas

Découvrez comment Swiss MPC accompagne les fabricants de dispositifs médicaux dans leurs projets réglementaires complexes.

Orthopedic Implants8 months

MDR Transition for Class III Implant Manufacturer

Leading European orthopedic implant manufacturer

Key Results

55%

Timeline reduction

100%

First-submission acceptance

200+

Products transitioned

1,400+

Documentation gaps closed

Regulatory StrategyTechnical DocumentationClinical Affairs

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Multi-device portfolio (Class I through Class III)12 months

Enterprise UDI Implementation Across 500+ Devices

Fortune 500 medical device conglomerate

Key Results

500+

Devices registered

Zero

Compliance gaps at audit

3 months

Ahead of deadline

4 sites

Global coordination

UDI CompliancePackaging & LabelingRegulatory Strategy

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Software as a Medical Device (SaMD)6 months

IEC 62304 Compliance for AI-Powered Diagnostic Software

Health-tech startup developing AI-powered diagnostic imaging software

Key Results

CE marking

Successfully achieved

IEC 62304

Full Class B compliance

IEC 81001-5-1

Cybersecurity documented

6 months

Completed on schedule

Software & CybersecurityRegulatory StrategyTechnical Documentation

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Pharmaceutical / Combination Products10 months

EU MDR Compliance for Drug-Eluting Combination Device

Mid-size European pharmaceutical company

Key Results

Achieved

EU market approval

1st attempt

NBO accepted without major findings

Zero

Major findings at regulatory audit

2 months

Ahead of projected timeline

Regulatory StrategyPharma Combination ProductsClinical AffairsTechnical Documentation

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