Consulting for medical device regulatory affairs, quality systems and global market access
Ganymede Consulting GmbH
SwitzerlandNew on Amplifa
About Ganymede Consulting
Ganymede Consulting GmbH is a specialized consulting firm for medical device regulatory affairs based in Switzerland. The company supports manufacturers of medical devices, drug delivery systems and laboratory equipment with regulatory strategies, technical documentation and the development of quality management systems according to ISO 13485. The services include regulatory submissions such as 510(k), De Novo, Technical Files and Design Dossiers, approval compliance according to IEC 60601 and IEC 61010, risk management according to ISO 14971, usability engineering according to IEC 62366, as well as post-market surveillance and audit preparation for Notified Bodies and FDA inspections. Founder and Managing Director David Clerk brings over 30 years of experience in regulated industries, including aerospace and the development of infusion systems, auto-injectors and proton therapy systems. The team consists of senior consultants with auditing and engineering expertise. The goal is the accelerated and compliant market launch of medical devices in the EU, USA and international markets.
- Site
- Switzerland
- Processes
- Medical Device Regulatory Consulting, Regulatory Strategy (EU, US, MDR, IVDR, FDA), Quality Assurance / ISO 13485 QMS, Technical Documentation (Technical Files, Design Dossiers), Device Safety Certification (IEC 60601, IEC 61010), Risk Management (ISO 14971), Usability Engineering (IEC 62366), Regulatory Submissions (510(k), De Novo)
- Materials
- Regulatory Strategy, QMS Development, Risk Management, Usability Engineering, Device Safety Certification, Post-Market Surveillance, Audit Preparation, Expert Training
- Certificates
- ISO 13485 Lead Auditor (Team)
- Founded
- 2009
- Industries
- Medical Technology, Medical Devices, Pharmaceutical Delivery Devices (Drug Delivery), Laboratory Equipment
- 01
Regulatory Intelligence
- 02
Regulatory Strategy
- 03
Technical Documentation
- 04
QMS Development
- 05
Risk Management and Usability Engineering
- 06
Regulatory Submissions
- 07
Post-Market Surveillance
Services and Standards
Regulatory Strategy
Regulatory approval strategies for EU, USA and international markets including MDR, IVDR and FDA.
QMS Development
Establishment and maintenance of quality management systems according to ISO 13485.
Risk Management
Risk management processes from hazard identification through risk control and verification.
Usability Engineering
Usability engineering processes for safe and effective user interfaces.
Device Safety Certification
Safety assessments for medical and laboratory electrical equipment according to IEC 60601 and IEC 61010.
Post-Market Surveillance
Establishment of PMS systems for market surveillance and device performance.
Audit Preparation
Gap analyses and remediation plans for Notified Body and FDA inspections.
Expert Training
Specialized training on medical device regulatory affairs.
Locations
Switzerland
CHHeadquarters
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical Device Regulatory ConsultingEngineering | – | – | – | – | – |
| Regulatory Strategy (EU, US, MDR, IVDR, FDA)Engineering | – | – | – | – | – |
| Quality Assurance / ISO 13485 QMSTesting | – | – | – | – | – |
| Technical Documentation (Technical Files, Design Dossiers)Engineering | – | – | – | – | – |
| Device Safety Certification (IEC 60601, IEC 61010)Testing | – | – | – | – | – |
| Risk Management (ISO 14971)Testing | – | – | – | – | – |
| Usability Engineering (IEC 62366)Engineering | – | – | – | – | – |
| Regulatory Submissions (510(k), De Novo)Engineering | – | – | – | – | – |
| Post-Market SurveillanceTesting | – | – | – | – | – |
| Regulatory IntelligenceEngineering | – | – | – | – | – |
| Audit PreparationTesting | – | – | – | – | – |
Additional services
Quality and Compliance
The company supports audit preparation, gap analyses and remediation plans for Notified Body and FDA inspections. Team members are long-standing ISO 13485 Lead Auditors.
| Evidence | Switzerland |
|---|---|
| ISO 13485 Lead Auditor (Team) |
History
- 2009
Foundation of Ganymede Consulting GmbH by David Clerk
- 2000
Previous CEO and founder activities of David Clerk (2000–2009, sold)