Safe Devices. Trusted Compliance.
ISO 13485 Certification Services in India
For manufacturers of medical devices, ISO 13485 proves your quality system meets global safety and regulatory standards.
OverviewISO 13485 is the international quality management standard for medical devices. It ensures the design, production, and delivery of medical equipment meets safety, performance, and regulatory compliance worldwide. Start Bharat helps device manufacturers, component suppliers, and healthcare startups implement ISO 13485 from scratch — including documentation, risk controls, traceability systems, and final certification coordination.
Who Is This For?This certification is vital for companies operating in the medical, diagnostics, and healthcare equipment industry.
Medical Device Manufacturers
Companies producing diagnostic, surgical, or monitoring devices that require regulatory acceptance and safety validation.
Component and Spare Part Suppliers
Vendors delivering key assemblies, casings, or electronic parts used in certified medical devices.
Biotech and Diagnostics Startups
Businesses innovating in rapid testing kits, molecular detection tools, or therapeutic devices that must pass audits.
Sterilization and Packaging Vendors
Units handling sterile packaging, labelling, or delivery of sensitive equipment that requires ISO conformity.
Exporters to Europe, US, or Japan
Indian companies needing global certification to qualify for CE, FDA, or WHO procurement tenders.
Solutions OfferedWe implement ISO 13485 by building your complete quality management system tailored to medical device compliance.
Benefits The standard builds global recognition, market access, and process discipline for medical equipment makers.
Step-by-Step ProcessWe simplify ISO 13485 implementation so your technical team stays focused while we handle the paperwork.
Device Study and Gap Assessment
We understand your product type, material flow, and determine required QMS scope and classification.
Document Drafting and QMS Policy Setup
We create full documentation, design risk processes, and vendor evaluation tools in line with ISO 13485:2016.
Team Training and Internal QMS Audit
We run internal audit drills, review each department’s implementation, and build readiness for external audit.
Final Audit Support and Certification
We coordinate with certifiers, resolve NCRs (if any), and help issue the final ISO 13485 certificate.
Frequently Asked Questions
We’ve amassed a large number of frequently asked questions (FAQs)
Yes. For regulated devices, it’s mandatory under Indian and global laws (e.g. CDSCO, EU MDR) for manufacturing and distribution.
Yes. If your work is used in or around medical devices, ISO 13485 helps meet your client’s QMS requirements.
Yes. We’ve worked with idea-stage and early prototype startups. Documentation is customized based on product readiness.
Typically 4–6 weeks if documents are ready and team is responsive. Final audit may depend on certifier availability.
ISO 13485 is the first step toward CE or FDA. While those involve further filings, this builds the base QMS.
No. Our consultants prepare and manage your system. Post-certification, we can help train an in-house QA if needed.