Medical Device Compliance Consulting

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

Defective medical devices endanger the safety of patients and users and have far-reaching consequences for manufacturers. As a result of past incidents, regulatory requirements have been tightened and the implementation of existing regulations and standards is subject to stricter scrutiny.

Develop and introduce a quality management system

Chemgineering supports you in the introduction of a compliant quality management system in accordance with e.g. EU MDR, US FDA and ISO 13485:2016. We bring our many years of industry experience to you. Together, we determine the scope of the project and select a suitable approach. It goes without saying that your individual needs are our priority. The systematic approach of our interdisciplinary team of experienced consultants includes solution development and implementation as well as support throughout the entire product life cycle.

Obtaining market approval and opening up new markets

Whether you are an established manufacturer looking to launch a new medical device, enter a new market or an innovative start-up dealing with regulations and standards for the first time: Medical device manufacturers and their suppliers must be able to present a coherent, reliable and compliant quality management system - and therefore safe and effective products - to the regulatory authorities in their target markets. If they cannot do this, they will not receive approval. Or lose their existing approval and can no longer serve their markets. We know the requirements of the authorities and provide you with guidance in the regulatory jungle.

Successfully pass audits on a regular basis

The international regulatory authorities have built up a well-functioning network. If a serious product incident is suspected in Australia, for example, this is communicated to the regulatory authorities worldwide within 24-72 hours and it is only a matter of time before the European regulatory authorities contact them to request detailed product information.

Global regulatory cooperation is also being driven by joint audit programs, such as the MDSAP (Medical Device Single Audit Program), a collaboration between Canada, USA, Brazil, Australia and Japan.  In addition, the practice of unannounced audits has become established. Both at national/regional level, e.g. based on the EU MDR or the US FDA Quality System Regulation, and at international level.

This means that, as an organization, you can expect an audit at any time - and must therefore be "all-time compliant". The previous practice of preparing for an audit/inspection at short notice no longer applies. In addition, continuous and consistent further development of the quality management system is significantly more cost-effective than event-driven emergency action.

The supply industry of medical device manufacturers is also involved in the above-mentioned initiatives: During the audit of a medical device manufacturer, their suppliers may also be audited. Medical device manufacturers must therefore ensure that their suppliers - even if they are not certified according to medical QMS standards - meet the requirements of the medical technology regulations and standards. Supplier management ("supplier controls") is therefore an essential element in order to be successful on the market.

With our specialists at your side, you can face an inspection by the authorities with complete peace of mind and bring your medical device safely and compliantly to your target markets.