+91 80984 42953 hello@sascert.in
Verify a certificate ISO standards library Download brochure
Medical

ISO 13485 Certification —
Medical Devices Quality

Meet the quality system requirements regulators and buyers expect from medical device makers and their suppliers.

Timeline3–6 weeks
Validity3 years
Price from[₹ price]
AuditOn-site / remote

Get your ISO 13485 price

Fill in your details and we'll send a customised quote.

Reply within 2 hours  •  No obligation

What is ISO 13485?

ISO 13485 specifies quality management requirements for organisations involved in the design, production, installation and servicing of medical devices.

It is widely used to support regulatory approvals and is often required by device makers from their component suppliers.

Who needs ISO 13485?

Device manufacturersComponent suppliersContract manufacturersDistributors

What you gain

Win more businessCustomers and tenders increasingly ask for this certificate.
Fewer problemsRisks are identified and controlled before they cause losses.
Clear processesEveryone knows what to do, and records prove it.
Customer trustAn internationally recognised mark on your quotes and website.
Legal readinessThe obligations that apply to you, tracked in one place.
Continual improvementRegular audits and reviews keep the system working.

ISO 13485 certification process

  1. 1Free consultation & quoteScope, price and timeline confirmed on the first call.Day 1
  2. 2Gap analysisWe compare your current way of working with ISO 13485 requirements.Week 1
  3. 3DocumentationPolicy, objectives, procedures and record formats made for your business.Week 1–2
  4. 4Training, internal audit & management reviewYour team learns the system; we audit it and close any gaps.Week 2–4
  5. 5Certification audit & certificateAn accredited certification body audits you and issues the certificate.Week 4–6

Documents we prepare for you

  • Policy and objectives
  • Scope and context document
  • Risk assessment and treatment records
  • Procedures and work instructions
  • Formats, registers and checklists
  • Internal audit and review reports

What we need from you

  • Company registration / GST certificate
  • Address of each location
  • List of products or services
  • Organisation chart and staff count
  • One coordinator from your team

ISO 13485 FAQs

01 How long does ISO 13485 certification take?

Most small and mid-size organisations are certified in 3–6 weeks. It depends on your size, locations and how much is already documented.

02 How long is the certificate valid?

Certificates are usually valid for 3 years, with a short surveillance audit each year. We help you prepare for those too.

03 Is the certificate accredited and verifiable?

Yes. Audits are done by accredited certification bodies, and your certificate can be verified online by customers and tender committees.

Get started today

Start your ISO 13485 today

Free consultation. Fixed price. Certificate in weeks, not months.

Get free quote WhatsApp us