Services Provided
ISO 13485:2003 / ISO 9001:2000
- Pre-assessments / Gap Analysis
- Procedure review and preparation
- Training / Implemenation Support
- Internal and Supplier Audits
MDD / IVDD CE Marking
- Pre-assessments / Gap Analysis
- Procedure review and preparation
- Training / Implemenation Support
- Technical File / Design Dossiers
Expert Witness
Expert Witness on the above topics |
510 (k) / PMA / Canadian Licenses
- Guidance and Preparation
- Liason with FDA / Health Canada
- Training and consulting
- Coordination with Third Party Review
Sterilization
- Ethylene Oxide / Gamma / E-Beam
- Validation Protocols & Reports
- Training and consulting
- Coordination with Contractors
More ...
New services coming |
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| About RCE |
| Our associates have worked for
leading device companies, Notified Bodies and ISO Registrars. We
provide support to companies ranging from a 2 person start up to
leading members of the Fortune 500 |
|