• Quality Management
    for Medical Devices & IVD

Do you need to implement, audit or remediate QMS processes?

A well-functioning Quality Management System (QMS) is key to ensuring product quality and regulatory compliance in the MedTech industry. However, building a compliant, yet lean QMS can be challenging. It requires specialised, cross-functional expertise.

With decades of experience managing diverse quality management systems of all sizes and complexities, we are uniquely positioned to offer you expert, tailored advice and support. We understand the challenges and know firsthand how vital an efficient QMS is to your success. ISS AG provides comprehensive support across the entire QMS lifecycle – from identifying regulatory requirements to QMS implementation, certification, operation, maintenance, and remediation when needed. Whether ISO 13485:2016 or 21 CFR 820, we are the right partner.

Our Expertise

  • QMS STRATEGY



    A solid QMS strategy sets the framework for how quality processes are integrated and managed across your organisation to meet regulatory requirements. However, creating a QMS or updating an existing one to meet evolving regulatory and business demands can be challenging.

    We simplify this process by developing customised Quality strategies that are aligned with your regulatory, clinical, and business objectives.

  • QMS IMPLEMENTATION



    We ensure that your Quality Management System (QMS) is designed to meet the needs of your company’s current development stage - whether you are a start-up or a global enterprise. Our experts optimise process interfaces to eliminate redundancies and enhance operational efficiency, ensuring regulatory compliance and effectiveness at every level.

  • QMS GAP ANALYSIS



    The MedTech regulatory landscape is constantly evolving, making it challenging to keep your QMS up to date. Additionally, internal changes –such as the need to address company growth, process inefficiencies, or adapting to new operational requirements – can also create gaps in your system. A QMS Gap Analysis helps you identify these weaknesses.

    Our experts conduct a thorough gap analysis and provide detailed, documented feedback to ensure your system remains compliant and efficient.

  • QMS AUDIT SUPPORT



    Audits can pose significant challenges for MedTech companies, from planning to execution and follow-up.

    We offer a team of trained and qualified auditors to support you in key areas, including:
    • Establishing internal and supplier audit programs
    • Planning and conducting internal, supplier, and mock audits
    • Providing support during external audits (e.g. by Notified Body or Competent Authority audits)
    • Managing audit deviations and support in audit follow-up

    Our experts ensure a smooth audit process and help you maintain compliance.

  • NON-CONFORMITY MANAGEMENT



    Non-conformities, complaints and CAPAs can be difficult to analyze and efficiently resolve. If not managed correctly and on time, they can lead to severe regulatory impacts.

    We provide expert support in all aspects of issue management and follow-up, ensuring proper handling and documentation to meet regulatory deadlines. Our Quality and Regulatory Managers also guide you through the challenges of executing a Field Safety Corrective Action, ensuring compliance and minimising disruption.

  • SUPPLIER MANAGEMENT



    Effective supplier management ensures product quality, regulatory compliance, and reduces business risks. However, it can be complex due to evolving regulations and supply chain variability.

    We assist you in optimising supplier qualification and evaluation processes, conducting supplier audits, and setting up robust quality agreements to ensure continuous improvement and operational efficiency.

  • QMS FOR ECONOMIC OPERATORS



    Under the EU MDR and Swiss MedDO, importers, distributors and CH Representatives of medical devices and IVDs face new regulatory obligations, including the need to establish and maintain a QMS that meets these requirements.

    Our experts offer comprehensive guidance on navigating Swiss and European regulations, helping you establish a compliant QMS or efficiently integrate these requirements into your existing system, ensuring compliance while maintaining operational efficiency.

  • COMPUTERIZED SYSTEMS VALIDATION (CSV)



    Medical device regulations place high expectations on the controls of SW that supports a manufacturer’s QMS execution. Our experts can support you with planning, requirements engineering, development, testing and documentation of your QMS-supporting computerised systems.

  • QMS TRAININGS



    Whether you require a high-level overview or in-depth expert knowledge, we offer customized training and workshops on key Quality Management topics, including MDR/IVDR, US FDA QMS requirements, ISO 13485, and MDSAP, and more. Our training sessions, available on-site or online, include a certificate of participation and can be tailored to your specific needs.

How can we support you?

We look forward to helping you build or maintain a successful QMS. Contact us today for tailored support.

Deborah Rossier

Deborah Rossier

Head of Quality & Engineering

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