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ISO 13485:2016

Medical devices

⏱ Timeline: 25 days to 3 months
📋 Start: Gap analysis
🤝 Turnkey, with accredited partners
Get a cost estimate Write on Telegram

What is it

Quality management system standard for organizations working with medical devices — manufacturers, suppliers, service organizations. A key requirement for entering regulated medical product markets.

Who needs ISO 13485:2016

  • Manufacturers of medical devices and equipment
  • Suppliers of components for medical devices
  • Distributors and service companies of medical equipment
  • Companies preparing to register products in foreign markets

What your company gets

  • Fulfilment of medical device market regulator requirements
  • A basis for product registration abroad
  • Trust of clinics, buyers and partners
  • Systematic management of product-related risks
  • Traceability at all lifecycle stages

How implementation works

Timeline — from 25 days to 3 months, depending on your company's current readiness. We set the exact timeline after the Gap analysis.

1

Gap analysis

We assess the current state and deliver a nonconformity map and work plan

2

Documentation

We develop the required documentation tailored to your practice

3

Implementation

We train staff, launch processes and conduct an internal audit

4

Audit

We support the certification audit until you receive the certificate

What it costs

The cost depends on your company's scale — number of employees, sites and processes. Leave a request and within a day we will calculate the exact cost and timeline for your case. The estimate is free and non-binding.

Frequently asked questions

How does ISO 13485 differ from ISO 9001?
ISO 13485 is a specialized standard for medical devices with strengthened requirements for risks, traceability and documentation. For the medical industry it replaces ISO 9001.
Is it mandatory for registering a medical device?
In many regulated markets, an ISO 13485-certified QMS is a mandatory element of the registration dossier.
Can it be combined with GMP?
Yes, for a number of directions this is standard practice. We design a single system without duplicating documentation.
Do you work only in Uzbekistan?
No. Our team has international experience: we work with CIS countries (Kazakhstan, Tajikistan, Russia — including Moscow) and beyond, including the UAE and Dubai. We run projects remotely and with expert site visits.

ISO 13485:2016 certification in Uzbekistan — Altavis Group

Get a ISO 13485:2016 certificate in Tashkent and across Uzbekistan: Samarkand, Fergana, Andijan, Bukhara, Navoi, Nukus and other regions. The cost of ISO 13485:2016 depends on the number of employees and sites — an exact free estimate after a Gap analysis. Certification timeline — from 25 days to 3 months. ISO 13485:2016 for tenders, public procurement, export and work with major customers. Turnkey system implementation: documentation development, staff training, internal audit, certification audit support. Consultation on ISO 13485:2016 in Uzbekistan — free.