Market Access for Medical Devices and Software

Are you developing software or hardware for medical or health-related purposes and want to bring them to the market? Then you face lots of laws, regulations, directives, guidelines and standards, since you must prove that your product is safe and fulfills its purpose before you can place it on the market.

Due to the new European Medical Device Regulation (MDR), the effort for CE marking of medical devices has increased significantly. The CE mark is a prerequisite for marketing a medical device in the European Union. You also need it if you want to apply for a Digital Health Application (DiGA) in order to get access to the German reimbursement system. But before that happens, you have to pass through a jungle of regulations and your product must meet a number of requirements. We can help you with our many years of experience. Together with you, we bring your new product to the regulated market safely, quickly and with as little effort as possible.

We advise and support you in all questions relating to the approval and certification of medical devices and software. Our focus is on medical apps, digital health applications (DiGA), medical device software and artificial intelligence (AI) applications.

Our processes are lean and are particularly suitable for start-ups and agile, innovative companies. Or for those who want to become one despite regulation.

Our consulting services in detail:

Certification and Approval

The aim is to bring a medical device onto the market. Strictly speaking, in the EU this is not an approval, as the manufacturer himself declares conformity with the requirements of the applicable EU directives or regulations and then attaches a CE mark. In order to be able to do this, the manufacturer must meet a large number of requirements. Possibly, the manufacturer must consult a notified body, which issues a corresponding certificate. We support you in all necessary steps:

  • Clarification whether it is a medical device at all
  • Formulation of the intended purpose
  • (Risk) classification of the product
  • Compilation of all approval requirements
  • Compilation of all relevant laws, guidelines, ordinances, standards and relevant recommendations
  • Development of an approval strategy and selection of the conformity assessment procedure
  • Selection of a notified body
  • Declaration of conformity and CE marking
  • Accompanying documentation and instructions for use
  • Registration requirements

Get more information here: The EU Medical Device Regulation (MDR): What is changing?

Quality Management

A functioning quality management system is a prerequisite for the approval of medical devices and a real added value if it is well thought out and lean. The new European Medical Device Regulation (MDR) makes a quality management system mandatory. We work with you to do what is efficient and necessary:

  • Analysis of the current situation
  • Gap analysis considering the product properties, risk management, conformity assessment procedure, etc.
  • Establishment of a quality management system according to ISO 13485
  • Support during certification and audits by a notified body

Get more information here: Quality management for medical devices – ISO 13485

Risk Management

The use of medical devices is always associated with risks for patients and users. Manufacturers must therefore carry out a risk management process. The European Medical Device Regulation (MDR) requires a risk management process along the entire product life cycle. We support you in:

  • Development of a risk management process according to ISO 14971
  • Creation of a risk management plan
  • Definition of risk acceptance criteria
  • Implementation of hazard and risk analyzes
  • Systematic assessment of risks
  • Risk minimization and post-market monitoring

Get more information here: Risk management for medical devices – ISO 14971

Usability Engineering

The usability of medical devices has become increasingly important due to the European Medical Device Regulation (MDR). We help you to optimize your product and document the results as part of the risk management process:

  • Development of a usability engineering process according to IEC 62366
  • Usage and requirements analyzes
  • User interface design
  • Usability evaluations
  • Link with risk management

Get more information here: Usability Engineering for Medical Devices – IEC 62366

Medical Software

Medical software places special demands on the conformity assessment. Here, too, the requirements placed on manufacturers by the European Medical Device Regulation (MDR) have increased significantly. We show you how to bring your software to market quickly and agilely:

Get more information here:
Medical software – classification and approval as medical device
Software life cycle for medical devices – IEC 62304

Clinical Evaluation

Manufacturers must use clinical data to verify that their product is safe and does what it is supposed to. We recommend starting the clinical evaluation as early as possible. We support you in:

  • Acquisition of clinical data through systematic analysis of different sources
  • Preclinical evaluation
  • Planning, implementation and documentation of the clinical evaluation
  • Clinical gap analysis
  • Planning a clinical trial

Get more information here: Clinical evaulation of medical devices according to MDR

Technical Documentation

The technical documentation is a compilation of all relevant documents for a product. It must be kept up to date throughout the entire product life cycle. The technical documentation is the basis for the conformity assessment and thus for the CE marking of a product. Together with you we put together all the necessary components:

  • Product description
  • Manufacturer information
  • Design and manufacture
  • Basic safety and performance requirements
  • Risk-benefit analysis and risk management
  • Verification and validation
  • Creation of a medical device file in connection with the quality management
  • Technical documentation after placing on the market

Get more information here: Technical documentation of medical devices according to MDR

Post-Market Surveillance

Manufacturers are legally obliged to monitor whether the safety and performance of their medical device are guaranteed even after they have been placed on the market (Post Market Surveillance, PMS). This includes the clinical evaluation (Post-Market Clinical Follow-Up, PMCF). Our services in terms of PMS and PMCF:

  • Development of a PMS or PMCF process
  • Gap analysis related to the risk / benefit ratio
  • Creation of a PMS / PMCF plan
  • Collection and analysis of data
  • Planning of PMCF clinical trials
  • Creation of the PMS documentation and reports

Get more information here: Post market surveillance and vigilance of medical devices according to MDR

Electrical Safety

Medical devices must be designed in such a way that the risk of electric shocks, bruises, explosions, unwanted exposure to radiation, etc. is minimized. For this purpose, the applicable standards of the IEC 60601 series should be complied with and the products tested accordingly. We support you in the design, compliance and testing in the following areas:

  • Electrical safety
  • Acoustics and noise emissions
  • Chemistry and sustainability
  • Electromagnetic compatibility (EMC)
  • Environmental simulation test
  • Radiation protection

Get more information here: Electrical safety for active medical devices – the IEC 60601-1 standard

In House Workshops

We offer several workshops and consultation days on a regular basis. In order to provide you with the necessary know-how, you can book our experts for a (digital) in house workshop. Find out more about our tailor-made offers.

> Contact us

Testing and Certification of Medical Devices

Medical devices are subject to a number of safety requirements, because the level of protection for users and operators must be understandably very high. A large number of product tests are therefore required. Take advantage of the longstanding testing expertise of the VDE Institute for active medical products including medical software. The VDE Institute offers a range of different certifications and has corresponding accreditations in accordance with DIN EN ISO / IEC 17025: 2018-03 and ISO / IEC 17025: 2017.

> Check VDE Institute

Check for Medical Devices and Personal Protective Equipment

Medical devices and personal protective equipment must have an EU declaration of conformity. This is a prerequisite for the CE mark and thus for marketing in Europe. We check the declaration of conformity or a corresponding certificate of a notified body for plausibility. This check allows a quick initial assessment of whether a product offered can be marketed and whether it comes from reputable sources.