Regulatory Compliance for Medical Devices: Individual solutions for the approval and surveillance (of your medical devices in your markets)

To ensure that your medical devices can be successfully and regulatory compliant marketed, it is crucial that you as a manufacturer meet the extensive and demanding regulatory requirements of your target market.

Here's where we come in: We offer you a comprehensive range of regulatory compliance services and stand alongside with you as a trustworthy partner. Our team of experts will accompany and support you throughout the entire product lifecycle of your medical devices.

Whether you are developing a new medical device, maintaining existing products, entering new target markets, or optimizing your quality management processes - with us, you will find customized and practical solutions for all your regulatory requirements. We are committed to helping you achieve your goals and meet your regulatory needs efficiently.

With Metecon, you have a strategic partner at your side who listens, thinks along with you and creates individual solutions. We understand your specific challenges and work closely with you to find the optimal path to market and post-market surveillance for your product.

Count on us. Together, we will ensure that your medical devices meet regulatory requirements and enable you to operate successfully in the marketplace.

Contact us today to learn how we can help you with your regulatory compliance needs.

Benefit from our regulatory expertise and optimize your market access today!

MedDO, MDR, standards and guidelines: Our services to ensure the regulatory compliance of your medical device.

Strategic consulting: We offer you in-depth strategic consulting to define your regulatory compliance goals and develop an effective action plan according to relevant regulatory requirements. These are, for example, the Medical Devices Ordinance of July 1, 2020; SR 812.213 (MedDO), the EU Medical Devices Regulation (EU) 2017/745 (MDR) as well as relevant processes from the standards EN ISO 14971, DIN EN 60601-1, DIN EN ISO 10993-1, DIN EN 62304, DIN EN 62366, IEC 62366-1, IEC 60601-1-6, EN ISO 10993-1 and the guidelines MEDDEV 2.7/1 rev. 4, MDCG 2020-5 and MDCG 2020-6.

Document verification, revision and creation: We support you in reviewing and revising your registration documents according to the requirements of the MedDO/MDR and relevant standards. In addition, we create new documents for you that comply with regulatory requirements at all times.

Setup a suitable quality management system (QMS): Together with you, we analyze your existing QMS process or develop a customized quality management system (QMS) that meets the regulatory requirements of ISO 13485 and above all: that is actively lived in the company! We support you in the implementation and optimization of all necessary processes.

Support in cooperation with testing laboratories, Swissmedic, German, and European Notified Bodies: We help you find suitable partners for testing, certification, and in cooperation with Swissmedic and the Notified Bodies in the EU. In addition, we support you in communicating and coordinating with these partners to ensure a smooth process.

Knowledge transfer, training, and workshops: Through our customized solutions and training, we empower you to transfer knowledge to your team effectively. We also offer cross-departmental training and workshops on all regulatory topics in the product lifecycle to improve mutual understanding and collaboration between teams.

Representative Services: As your EU Authorized Representatives (EC-REP), Swiss Authorized Representative (CH-REP), and/or PRRC (Person Responsible for Regulatory Compliance), we take care of your legal obligations and ensure smooth communication with the relevant authorities.

Temporary Manufacturer Responsibility: Through our sister company CEyoo GmbH, we can handle temporary manufacturer responsibility for your products.

Support in the selection of digital solutions: We are here to assist you in selecting digital solutions for your regulatory requirements in the field of Medical Devices. We support you in analyzing your specific needs and choosing suitable software to efficiently and successfully handle your compliance tasks.

Discover how we can help you with your specific challenges. Contact us now!

We are looking forward to hearing from you

Our Services in detail

Complete support for your Quality Management System (QMS) in Switzerland, Europe, USA and other countries:

  • Creation of processes and documents for an effective Quality Management System (QMS) according to ISO 13485.
  • Implementation of interfaces between your quality management system (QMS) according to ISO 13485 and the international regulatory requirements for the marketing of medical devices.
  • Development of processes according to national/international regulatory requirements (MedDO, MDR and others).
  • Creation of processes such as CAPA (Corrective and Preventive Action) based on the international regulatory requirements of the respective target market.
  • Undertaking the role of interim quality management representative.
  • Performing GAP analyses between ISO 9001 and ISO 13485.
  • Execution of GAP analyses between ISO 13485 and regulatory requirements according to MedDO, MDR and others.

Your documentation and quality management system (QMS) complies with all requirements:

  • Conducting internal audits according to ISO 13485, MedDO, MDR, and other regulations as well as MDSAP.
  • Partial or complete preparation of a sustainable management review.
  • Support along the way to certification of the quality management system (QMS) in accordance with ISO 13485.
  • Support in processing deviation reports from external audits and communicate with Swissmedic, European Notified Bodies as well as international Notified Bodies.

Our services for your Clinical Affairs:

Clinical evaluations according to MEDDEV 2.7/1 Rev. 4 and relevant MDCG Guidelines are critical to meet regulatory requirements for medical devices. We offer complete support in the preparation of such evaluations for products already on the market or preclinical evaluations during product development.

  • Scientific and recorded literature search:
    • Thorough and well-documented planning and execution of literature searches.
    • Evaluation and analysis of current data from the scientific literature..
    • Analysis of market data and information.
    • Contacting medical experts.
    • Evaluation of your documents and results of clinical studies.
    • Comparing the results with the current state of medicine and science.

For a successful orientation to the future, it is essential not only to have the necessary know-how for Clinical Evaluations but also to understand the actual clinical functions of your product and to continuously demonstrate its efficacy and safety: Post-Market Clinical Follow-up (PMCF).

  • Support in meeting PMCF requirements and updating Clinical Evaluations throughout the product life cycle.

Consulting, training, and workshops on Clinical Evaluation and PMCF according to applicable regulations and their effective implementation in your company according to your individual processes.

Our regulatory affairs service for your international approval includes:

  • Support in the preparation of the regulatory submission documents according to the requirements for the approval of medical devices in different countries, such as Switzerland, Europe (CE), USA (FDA), TGA, MDL, CFDA, and PMDA.
  • Preparation of regulatory submissions for international registration procedures.
  • Supervised registration procedures, including planning and preparation of amendment and renewal applications.
  • Conducting research on specific regulatory requirements for defined target countries, such as UDI (Unique Device Identification), classifications, etc.

We develop your approval strategy in an ideal way:

  • Research and training on national and international regulations, procedural guidelines and principles,
  • Ensuring regulatory compliance with your medical devices:
    • Analysis of (inter)national legal requirements, as well as the development and further enhancement of corresponding approval strategies,
    • Establishing and maintaining contacts with national and international regulatory authorities, certification bodies, notified bodies, and national and international health authorities,
    • Keep informed about changes in national and international legislation, as well as underlying scientific and political influences,
    • Responding to regulatory issues (e.g. UDI implementation).

Use our expertise to meet your regulatory requirements and successfully bring your products to market. Contact us today!

Where is your Compliance Journey headed?