MS Certification Services

ISO 13485:2016 & EN ISO 13485:2021

ISO 13485:2016 & EN ISO 13485:2021 – Medical Device Quality Management Systems

At AQC, we provide expert consultancy to help Medical Device and In Vitro Diagnostic (IVD) manufacturers achieve compliance with ISO 13485:2016 and EN ISO 13485:2021. These international standards define the quality management system (QMS) requirements for organizations involved in the design, production, installation, and servicing of medical devices.

What is ISO 13485?

ISO 13485 is the globally recognized quality management system (QMS) standard specifically designed for medical device manufacturers and related industries. Compliance with ISO 13485:2016 or EN ISO 13485:2021 ensures that medical devices meet regulatory requirements, patient safety standards, and quality assurance protocols.

Key Benefits:

Ensures compliance with EU MDR (2017/745) & IVDR (2017/746)

Enhances product safety, quality, and risk management

Required for CE Marking and medical device regulatory approvals

Improves efficiency, traceability, and regulatory compliance

Our ISO 13485 Consultancy Services

Training & Awareness Programs

  • Providing training sessions for teams on ISO 13485 implementation, risk management, and documentation requirements

Internal Audits & Gap Analysis

  • Identifying non-conformities and preparing for certification audits
  • Conducting internal audits to ensure ongoing compliance

Regulatory Compliance & CE Marking Support

  • Aligning ISO 13485 QMS with EU MDR 2017/745 & IVDR 2017/746
  • Supporting manufacturers with CE Marking and Notified Body interactions

ISO 13485 Implementation & Certification Support

  • Assisting manufacturers in setting up an ISO 13485-compliant QMS
  • Preparing documentation, policies, and standard operating procedures (SOPs)

ISO 13485:2016 vs. EN ISO 13485:2021

Standard Scope
ISO 13485:2016 International version applicable globally
EN ISO 13485:2021 European version harmonized with EU MDR & IVDR, containing additional Annexes Z that align with EU regulations

*EN ISO 13485:2021 is essential for manufacturers targeting the European market, as it aligns directly with EU MDR & IVDR.

Who Needs ISO 13485 Certification?

Contract Manufacturers & Suppliers

Contract Manufacturers & Suppliers

Medical Device & IVD Manufacturers

Medical Device & IVD Manufacturers

Distributors & Importers

Distributors & Importers

EU Authorized Representatives

EU Authorized Representatives (E.A.R.)

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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