ISO 13485 QMS, CE Mark / MDR, BIS, FDA QSR, and GMP — implementation, internal audit, and certification body liaison under one roof.
Why teams choose us
Every artefact mapped to international standards from day one.
Gap analysis, SOP rollout, training, internal audit, certification body liaison.
Technical documentation, notified-body engagement, CE certificate.
Indian standard compliance for devices requiring BIS registration.
US-market readiness, 510(k) supporting QMS documentation.
Mock audits, gap remediation, and corrective action plans.
Versioned SOPs, training records, audit trail — built for inspection.
An average ISO 13485 engagement closes in 8–10 weeks.
Full QMS audit against ISO 13485 with a remediation roadmap.
SOPs, work instructions, forms, and records — versioned and traceable.
On-site or remote training for QA, operations, and leadership.
Full audit by our lead auditor with non-conformance report.
Document review with the certification body. We attend.
On-site audit, CAPA closure, and certificate issuance.
We work regularly with leading notified bodies — faster scheduling, smoother audits.
“The certification process was well organised and our Stage 2 audit went smoothly with strong preparation.”
Certified ISO 13485 auditors run your internal audit before the real one.
Clients we guide through Stage 2 are prepared to clear on first attempt.
Single QMS engagement that serves all three markets simultaneously.
ISO 13485 certification achieved
An In Vitro device startup had no established QMS and needed ISO 13485 certification. We developed the full documentation, implemented SOPs and quality procedures, ran internal audits, and trained the team.
Complete
QMS documentation
Implemented
SOPs & procedures
Trained
Quality team
Achieved
ISO 13485 cert
Quick answers about scope, timelines, and how this engagement runs.
Ask us directlyTypical: 8–10 weeks from kick-off to Stage 2 audit. Faster paths exist for mature operations with existing documentation.
We prepare you for the audit. Certification is issued by an accredited notified body — we manage their engagement on your behalf.
Yes. We design a harmonized QMS that maps each procedure to all three frameworks, eliminating duplicate documentation.
Annual surveillance audits and a recertification audit every 3 years. We support ongoing maintenance as a retainer.
Yes — we manage the full MDR transition including gap analysis, updated technical documentation, and notified body re-engagement.
Send us your current QMS state. We’ll return a roadmap and fixed-scope quote within 48 hours.