ISO 13485 Certification Services

Overview

ISO 13485 Quality Management System for Medical Devices

ISO 13485 is the most accepted standard worldwide for manufacturers of medical. The standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition, important terms have been defined including: medical device, active medical device, active implanted medical device, sterile medical device, and many more.

ISO 13485 is the most accepted standard worldwide for manufacturers of medical. The standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition, important terms have been defined including: medical device, active medical device, active implanted medical device, sterile medical device, and many more.

Certification Benefits

Eligibility for submitting tenders or proposals for projects.

Evidence of adherence to legal and regulatory or contractual requirements

Generates new business opportunities

Can boost your organisation’s brand reputation and be a useful promotional tool, especially when going up against competitors who aren’t certified

Guarantees high quality of provided services and products

Reduces production loss rate

Reduces operational costs

Increases effectiveness across the whole organisation

Increases your customers‘ trust in you as a safe supplier or producer

Minimize corporate risk

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