Certification and quality management systems
Turnkey QMS implementation and certification readiness: ISO 13485 for medical device manufacturers, internal quality control under Order 785n for clinics, ISO 9001 for tenders. Documentation on a production line, methodology built for inspection.
It depends on what you do. If you manufacture medical devices - ISO 13485 and an ISO 14971 risk file for EAEU registration. If you run a clinic - internal quality control under Order 785n. If you bid in tenders - ISO 9001 for scoring points. We choose the direction during a short brief.
For registering medical devices under EAEU rules, a quality management system is mandatory and its operation is checked by a production inspection. For clinics, internal quality control under 785n is a standing obligation. In tenders, an ISO 9001 certificate is not always mandatory but earns extra points.
Usually 30-60 documents: quality manual, SOPs, policies, record forms, risk management file, audit programmes and checklists. The exact scope depends on device risk classes, site size and whether it is a manufacturing site or a clinic.
Turnkey implementation takes 3-5 months: a readiness audit from 1 week, implementation and documentation roughly 2-12 weeks, then inspection prep before the conformity assessment. We fix the timeline after the gap analysis.
A QMS cannot be implemented once and forgotten. Maintenance means internal audits, document updates and recertification prep. We run this stage on a retainer so the system stays alive rather than going stale before the next inspection.
Passing an inspection cannot be guaranteed on behalf of a third party - and we do not promise it. We guarantee something else: fixing any findings against our documentation at our own expense. The methodology is validated by a specialist expert by device risk class.