ISO 13485 – guided by en.co.tec!
ISO 13485 is the most important standard for medical device manufacturers.
The purpose of ISO 13485 is to provide manufacturers with specific guidance for developing a quality management system. This is intended to ensure that products and services comply with legal requirements.
ISO 13485:2016 is the state-of-the-art standard for medical device manufacturers and is, in fact, also a requirement for suppliers of components and assemblies. The focus is on regulatory compliance, risk management, traceability, and expanded documentation requirements.
Around 25,000 organizations worldwide are certified according to ISO 13485. en.co.tec is proud to have made a significant contribution to this number, having supported around 75 quality management system certifications to ISO 13485 in the DACH region alone!
Support from en.co.tec – how can we help you?
Whether you already have a quality management system (QMS) in your company, such as ISO 9001, or whether we implement a quality management system together – we support you in three simple steps, tailored to your needs, to ensure that you meet the quality management requirements of the EU regulations (MDR / IVDR) and/or ISO 13485 right from the start.
No unnecessary documentation—just exactly what you need!
Guidance and support in all phases of ISO 13485 implementation:
- Step 1: Assessment and introduction
Once you have chosen a system, our professional consultants will support you with the analysis, implementation, and documentation of your quality management system processes. - Step 2: Auditing
The established QMS is reviewed by an independent en.co.tec auditor as part of an internal audit. If you already have an existing quality management system in your company, the assessment will also take place in the form of an internal audit. - Step 3: Certification
We take care of the certification body (for ISO 13485) and/or the notified body (for EU regulations (MDR/IVDR)), and support you during the Stage 1 audit and the certification audit.
What happens after certification?
Once your ISO 13485 system certificate has been issued, we are happy to support you with our:
“3-Year All-Inclusive” ISO 13485 Package
- Maintenance of the quality management system with one internal audit per year and
- and significantly discounted priority access to our consulting and training services.
Special topics related to ISO 13485:
We have specialized expertise when it comes to linking regulatory requirements relevant to medical device approval with general quality management system requirements, for example:
- Software development: ISO 13485, Software life cycle processes (EN 62304), risk management (ISO 14971), while simultaneously preparing the technical documentation for product approval.
- Newcomers to medical technology (as a supplier, manufacturer with established quality management systems)
Are you planning to implement ISO 13485?
We are happy to help you!
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Call us at: +43 1 8863491 or email us: office@encotec.at.
