Consulting
Consulting
Consulting

Culture of quality

When manufacturing medical devices many regulations must be complied to. We are happy to offer you competent advice and support on the below shown topics based on our specialised knowledge and many years of experience. Our aim is always to find the optimal solution for you.

QM is essential in medical technology. We implement your request in a goal-oriented and reliable manner.
Internationally, markets for medical devices are regulated differently. We guide you through the jungle of requirements.
Constant verifiability and control are the benchmark for a good product - we advise you in detail.
Urgency is the order of the day. Whether you have a suspicion of an incident, a report on it or a possible recall, we are there for you!
Whether it's work process challenges or specialist expertise, discover what we can also support you with.
Consulting

Quality management

To create maximum transparency including ensuring an efficient and economically successful focus on the customer we combine all information thus making them easily accessible throughout your company. We implement your requirements in a targeted and reliable manner to offer you the best possible benefits. Providing you an experienced staff force with our experts we support you in all the various areas and offer our practical knowledge.

Consulting

Regulatory Affairs

When it comes to the approval of medical devices it is of great importance to efficiently comply with international regulations. With the advice from our experts, we offer you an advantage not only with the current MDR and IVDR regulations. We have the necessary expertise and competence to support you for market access in several countries. Our aims to provide you with comprehensive solutions meeting all your requirements.

Consulting

Audits in the medical device industry

To carry out audits effectively it is important to have appropriately trained auditors. Our competent team of consultants provides you with experienced auditors. With an independent consultant our biggest advantage is the ability to protect you from major and minor non-conformances, e.g., with carrying out mock audits. This allows us to identify for you potential weaknesses and correct them BEFORE the actual audit takes place. Our aim is to prepare you in the best possible way for the important audits and to help you pass successfully.

Consulting

Reportable

In addition to the initial placing on the market, there is also a need for performance monitoring throughout the life cycle of a medical device, depending on the product class even to an increased extent. We offer in-depth consulting services regarding the handling of incidents, reportable events, quality management systems, post-market surveillance (PMS) and post-market clinical follow-up (PMCF), periodic safety update reports (PSUR) as well as for specific individual questions (micro-consulting).

Consulting

Further services

In the complex world of medical devices, we offer you support with the challenges mentioned above in addition to a wide range of other work processes. Our highly qualified consultants have extensive expertise from the entire healthcare industry and are available to support you with their expertise. No matter what challenges you are facing we can help you find customised solutions and optimise your work processes.