Medical Device Compliance consulting

Chemgineering assists you when introducing an audit-proof quality management system as well as in all questions regarding the regulatory requirements in medical technology.

With our specialists at your side, you can be relaxed about your upcoming public authority audits and bring your medical device safely and compliantly to your target markets.

For the safety of patients and users - and for your company's success

Faulty medical devices endanger the safety of patients and users and have far-reaching consequences for the manufacturers as well. Due to past incidents, regulatory requirements have been tightened and the implementation of already existing regulations & standards is being done more stringently.

Develop and introduce your quality management system

Chemgineering assists you when implementing a compliant quality management system according to e.g. EU MDR, US FDA and ISO 13485: 2016. We offer you the benefits of our many years of experience in the sector. Together with you we define the scope of the project and select the most suitable approach. Your individual needs, however, always take pride of place. The systematic approach of our interdisciplinary team of experienced consultants includes solutions development and implementation as well as support throughout the entire product life cycle.

Get your market approval and open up brand new markets

Whether you want to launch a new medical device on the market as an established manufacturer, open up a new market or, as an innovative start-up, are having to deal with regulations and standards for the very first time: Medical device manufacturers and their suppliers must be able to present a consistent, reliable and compliant quality management system - and thereby also safe and effective products - to the regulatory authorities of their target markets. If they cannot do this, they will not get approval. Or they will lose their existing license and can no longer serve their markets. We know the requirements of the authorities and provide you with some orientation in the regulatory jungle.

Audits are regularly passed

The international regulatory authorities have established a well-functioning network. As one example, in Australia, wherever a suspected product incident is suspected, it will be communicated to regulators worldwide within 24-72 hours, with it just being a matter of time before the European regulators announce themselves with a request for detailed product information.

Regulatory cooperation worldwide is also driven by joint audit programs, such as the Medical Device Single Audit Program (MDSAP), a joint undertaking between Canada, USA, Brazil, Australia and Japan. In addition, unannounced audits have now become an established practice. Both at the national and regional levels, e.g. based on the EU MDR or the US FDA Quality System Regulation, as well as at an international level. This means that as an organization, you should be able to expect them at any time - and in so doing be "all-time-compliant". The earlier practice of preparing for an audit / inspection at short notice is no longer valid today. In addition, continuous and consistent further development of the quality management system is significantly more cost-effective than "event-driven emergency action".

The suppliers of medical device manufacturers are also involved in the aforementioned initiatives: During the audit of a medical device manufacturer, their suppliers can also be inspected. Therefore, medical device manufacturers must ensure that their suppliers - even if not certified to medical QMS standards - meet all the requirements of medical device regulations and standards. Supplier management (supplier controls) is therefore an essential element for succeeding in the market.With our specialists at your side, you can be relaxed about your upcoming public authority audits and bring your medical device safely and compliantly to your target markets.

We advise you in the areas of Quality Management System Compliance, Audits & Inspections, Global Supplier Management, and Q & R Education:

  • MDD/IVD transition to MDR/IVDR
  • Preparation for ISO 13485:2016 certification
  • Support in the international approval of medicinal products
  • Implementation of internal and supplier audits
  • Supplier qualification and third-party audits worldwide
  • Preparation of audits by the notified body or regulatory authorities
  • Preparatory and follow-up work relating to inspections
  • Mock audits & GAP analyses
  • MDSAP compliance
  • US FDA / QSReg compliance
  • ANVISA compliance
  • Management of complaint handling
  • Risk management (ISO 14971)
  • Quality management: Optimization and implementation
  • Quality oversight & KPIs
  • Training on all quality-related subjects
  • Compliance consulting for combination products

Other topics

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