ISO 13485:2016 — Medical Devices QMS
For medical device design, manufacturing and service organizations.
Overview
ISO 13485:2016 sets out quality management requirements for organizations that design, produce, install or service medical devices. It adds strict controls for risk management, design, sterile production, traceability and complaint handling. Certification supports device registration with regulators and approval by hospitals, distributors and international buyers.
Benefits
- Market access for medical devicesThe quality system expected by regulators and buyers in most markets, including DRAP and international buyers.
- Patient safetyRisk management and controls across design, production, sterilisation and distribution.
- Supports regulatory approvalsA common basis for CE marking (MDR) and other device registrations.
- Full traceabilityDevice history records and complaint handling are controlled and documented.
- Supplier credibilityHospitals and distributors prefer certified manufacturers and suppliers.
Who needs it
Medical device manufacturers and assemblers, sterilisation and packaging service providers, component suppliers and distributors of medical devices and diagnostics.
How the process works
- Create your account and submit the online application.
- Upload the required documents.
- Our team reviews your application and schedules the assessment.
- Any findings are recorded and you respond online.
- An authorized person makes the certification decision.
- Your certificate is issued with a unique number and QR code, and appears in your portal for download.
Required documents
You'll upload these in your portal. Accepted formats: pdf, jpg, jpeg, png, doc, docx, xls, xlsx (max 10 MB each).
Frequently asked questions
Who can apply for ISO 13485:2016 — Medical Devices QMS?
Medical device manufacturers and assemblers, sterilisation and packaging service providers, component suppliers and distributors of medical devices and diagnostics.
How long does ISO 13485:2016 — Medical Devices QMS take?
Typically 2–6 weeks once a complete application and all required documents are received. The actual time depends on how quickly documents and any corrections are provided and on assessment scheduling. You can follow every step live in your client portal.
Which documents are required?
The main documents are: Company registration certificate (SECP / partnership deed); NTN certificate; Organization chart; List of products / services; Existing management system manual (if any). You upload them securely in your portal, and our team tells you if anything needs to be replaced.
How long is the certificate valid?
The certificate is normally valid for 3 years, subject to satisfactory surveillance where applicable. You receive renewal reminders before it expires.
How can I track my application?
Create a free account, submit the online application and upload your documents. Your portal shows the live status, messages from Pak CA, the expected completion date and any documents that need attention.
How can a customer verify my certificate?
Anyone can enter the certificate number on the Verify page of this website, or scan the QR code on the certificate, to see its current status, first issue date, last renewal and expiry.
Can Pak CA help with renewal?
Yes. Your portal shows how many days are left, you get reminders before expiry, and you can start the renewal application online in a few clicks.