ISO 13485 certification for medical device makers and suppliers.
Build a medical device QMS that satisfies CDSCO’s Fifth Schedule, the US FDA’s QMSR and EU MDR in one go. We set up design controls, risk management, supplier and production controls and records, train your team and coordinate certification with an accredited body.
What ISO 13485 certification gives you
Regulatory Readiness
Supports CDSCO licences, FDA and CE requirements. See CDSCO.
Controlled Design & Production
Design controls, validation, traceability and risk management throughout the device life cycle.
Customer Trust
Expected by hospitals, distributors and global device companies.
ISO 13485 certification: the key facts
| Standard | ISO 13485:2016 (EN ISO 13485:2016 + A11:2021 in Europe) |
| India | Medical Devices Rules, 2017, Fifth Schedule QMS aligned with ISO 13485 |
| USA | FDA QMSR effective 2 February 2026 incorporates ISO 13485:2016 |
| Related | ISO 14971 risk management; device testing. See Medical Device Testing |
| Cycle | 3 years with annual surveillance |
| Verify | IAF CertSearch |
| Consultant | Bizpro Compliance Services, New Delhi, prepares organisations for ISO certification and coordinates audits with accredited certification bodies across India: +91 920 500 6364, contact@bizprocompliance.com |
Who needs ISO 13485 certification?
ISO 13485 is the quality management standard for medical devices. Find your business to see where it’s required.
Showing all 6 industries and situations
| No. | Industry / Situation | Why it’s asked for | Driver | |
|---|---|---|---|---|
| 1 | Medical Device Manufacturers (India)Class A to D devices under CDSCO | QMS under the Medical Devices Rules aligns with ISO 13485 | Regulatory | |
| 2 | Exporters to the USDevices sold in the United States | FDA's QMSR, effective 2 February 2026, incorporates ISO 13485:2016 | Regulatory | |
| 3 | Exporters to EuropeCE-marked devices under EU MDR / IVDR | EN ISO 13485 is the harmonised QMS standard | Regulatory | |
| 4 | IVD ManufacturersDiagnostic kits, reagents and analysers | Required for CDSCO and export approvals | Regulatory | |
| 5 | Component & Contract ManufacturersSuppliers of parts, sterilisation, packaging | Required by device-maker customers | Buyers & exports | |
| 6 | Distributors & ImportersImporters, distributors and service providers | Often required by manufacturers and tenders | Tenders & GeM |
“” isn’t in this list
Tell us your industry and what the certificate is for (tender, buyer, export or regulator), and we’ll confirm the standard and scope.
Tell us what the product is and we’ll confirm which approvals it needs, free.
Sources: ISO standards and amendments as published by ISO; IAF transition and accreditation rules; NABCB; checked on 1 November 2026. Certification is issued by accredited certification bodies, verifiable on IAF CertSearch.
Get your ISO 13485 quote and timeline
Tell us your organisation, sites, employees and why you need the certificate. A specialist confirms scope, certification body, total cost and timeline, in writing.
- Reply within one business dayFrom a named consultant, not an automated sales sequence.
- Fixed written quoteGovernment fees, lab charges and our fee listed separately before you commit.
- Accredited bodies onlyNABCB / IAF-accredited certificates, verifiable online.
What ISO 13485 costs
Audit days depend on employees, sites and complexity under IAF rules. We get competing quotes from accredited bodies.
Request received
Thanks. A BIS specialist will reply within one business day with your standard, test plan, cost and timeline.
Send it with one tap instead
The form couldn’t send just now. Your details are ready in a message, so you only need to press send.
Make sure your ISO certificate is worth having
Tender committees, buyers and regulators increasingly check where a certificate came from.
Accredited certification bodies only NABCB / IAF MLA
We work only with certification bodies accredited by NABCB (India’s accreditation body under QCI) or another IAF MLA signatory for your standard and industry scope.
Verifiable online IAF CertSearch
Accredited certificates can be checked on IAF CertSearch, which many buyers and tender committees now do before accepting them.
Avoid ‘instant’ certificates Unaccredited
Certificates issued without a real audit, or by unaccredited bodies, are routinely rejected in tenders and audits and can damage your reputation.
Three-year cycle Surveillance every year
Certification runs on a three-year cycle: initial audit in two stages, surveillance audits in years two and three, then recertification.
Your ISO 13485 certification step by step
We prepare you; an accredited certification body audits and certifies. Timelines depend on your size and readiness.
Gap Analysis
Current practices checked against every clause; scope, sites and certification body agreed.
Week 1Documentation & Implementation
Policy, objectives, procedures, records and risk registers set up for how you actually work.
Week 2–6Training & Internal Audit
Awareness and internal auditor training; full internal audit and management review.
Week 6–8Stage 1 & Stage 2 Audits
Certification body reviews readiness, then audits implementation on site.
Week 8–12Certificate & Surveillance
Certificate issued for three years; annual surveillance audits supported.
OngoingISO certification support across India
Documentation and training are delivered online and on-site, and audits are scheduled with accredited certification bodies nationwide, including:
Common ISO certification mistakes
Copy-Paste Manuals
Generic templates that don’t match how you work fail on-site audits.
No Records
Auditors need evidence: records, monitoring results, internal audits and management reviews.
Wrong Scope
A scope that omits sites, products or services the buyer cares about makes the certificate useless for that tender.
Unaccredited Certificate
Non-accredited or unverifiable certificates are often rejected by GeM buyers, PSUs and exporters.
No Design History
Design and development files and risk management records are central to the audit.
Combine standards and save audit time
Standards with the same high-level structure can be audited together as an integrated management system.
ISO 9001 QMS
Quality management for any organisation. See ISO 9001 QMS.
ISO 14001 EMS
Environmental management. See ISO 14001 EMS.
ISO 45001 OH&S
Occupational health and safety. See ISO 45001 OH&S.
ISO/IEC 20000-1 ITSM
IT service management. See ISO/IEC 20000-1 ITSM.
ISO 22000 FSMS
Food safety management. See ISO 22000 FSMS.
Common questions about ISO 13485 certification
What is ISO 13485 certification?
Is ISO 13485 mandatory in India?
Is ISO 13485:2016 still the current version?
Does the US FDA accept ISO 13485?
How long does ISO 13485 certification take?
Is ISO 13485 the same as ISO 9001?
Get certified the right way
Tell us your organisation and why you need the certificate. We’ll confirm the scope, accredited certification body, cost and timeline in writing, free.