Years as a certifier at TÜV Rheinland and CSA Group, combined with in-house R&D and Design Control experience — built to find the shortest honest path to certification.
Certifier at TÜV Rheinland and CSA Group. Multiple years evaluating and certifying a wide range of Medical Electrical Equipment against the IEC 60601 series.
In-house medical device experience. R&D and Design Control work inside medical device manufacturers, across multiple QMS structures.
Regulatory approvals achieved. FDA 510(k) (United States), EU MDR (Europe), TGA (Australia), and PMDA (Japan).
Building an ISO 13485-based quality management system, from document architecture to Design Control processes.
Certification strategy and application support for IEC 60601-1 and its collateral and particular standards.
Pre-compliance test planning, gap analysis, and test report review before formal submission to a test lab.
Preparation of FDA 510(k), EU MDR technical documentation, and other regulatory submission packages.
Review device classification, applicable standards, and gaps in current documentation.
Define the required test plan and the scope of QMS documentation.
Hands-on support through testing, QMS build-out, or drafting submission documents.
Final review and support through the certification body or regulatory authority submission.
Tell us about your device and where you are in the process. We typically reply within 1–2 business days.