ISO 13485 Consulting and Training

What is ISO 13485?

ISO 13485 specifies requirements for a quality management system for medical devices and related services. It helps organizations consistently meet applicable customer and regulatory requirements. It is a sector-specific quality management standard, not a product safety certificate or an automatic authorization to market a device.

ISO 13485 emphasizes regulatory requirements for medical devices and is widely used by manufacturers and suppliers. Its recognition and any certification obligations depend on the applicable market and activity; a certificate does not automatically authorize worldwide sales.

Organizations involved in medical device activities can implement ISO 13485 independently or integrate relevant processes with other management systems. Hospitals and healthcare facilities should assess applicability to their particular medical device activities rather than assume it applies to every healthcare service.

The current edition is ISO 13485:2016, confirmed by ISO in 2025.

Who can apply ISO 13485?

ISO 13485 is relevant to organizations in the medical device supply chain, irrespective of size or location, according to their activities: design, manufacturing, installation, servicing, distribution and related services. Product examples include medical gloves, sterilization devices, needles, infusion tubing and feeding tubes. Determine the intended use and classification of each product.

Benefits of ISO 13485 implementation

1. Support delivery of devices meeting user safety requirements.
2. Strengthen competitiveness, brand confidence and readiness to meet export conditions.
3. Reduce waste, manage risk and support business performance without guaranteeing a particular revenue or profit.
4. Manage activities systematically to control product quality and safety.
5. Support improvements in workforce productivity.
6. Improve the ability to meet relevant customer and national, regional and international market requirements.
7. Strengthen competitiveness and opportunities for market expansion.
8. Improve the effectiveness and efficiency of the existing management system.

ISO 13485 consulting process

1. Assessment and report
2. Detailed planning
3. ISO 13485 interpretation training
4. Documentation
5. System implementation
6. Internal audit and management review
7. Certification audit preparation
8. Certification audit
9. Post-audit corrective actions

ITVC provides consulting and preparation support; an independent certification body conducts certification audits and makes certification decisions.

ITVC Global ISO 13485 services

Consulting

Consulting to establish and implement a medical device quality management system in accordance with ISO 13485

Training

• Awareness and interpretation of ISO 13485 requirements
• ISO 13485 internal auditor skills

Reference materials

ISO13485:2016 — Standard information

ISO13485 — A practical guide

ISO14971:2019 — Medical device risk management

ISO9001:2015 — Reference cited in the original article

Decree 36/2016/ND-CP — historical reference (Vietnamese)

Determine the rules and procedures applicable to each product, activity and implementation date. Start with the consolidated medical device regulation and relevant circulars; ISO 13485 certification does not replace regulatory procedures.

Ministry of Health — consolidated document 08/VBHN-BYT (2026, Vietnamese)

Circular 24/2026/TT-BYT (Vietnamese)