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Risk Management for Medical Devices

Safety and Compliance in Medical Technology Development

The safety of medical devices is a top priority – for patients, users and manufacturers alike. Structured risk management is not only required by law, but is also a key success factor for the authorisation and market success of your products.

Our team (consisting of risk managers, clinical experts, specialised engineers and regulatory affairs experts) supports you in implementing an effective risk management system that covers the entire life cycle of your medical device. A particular focus is placed on the clinical aspects of the product.

Benefit from our expertise and let us work together to ensure the safety and success of your medical devices.

Together, we Minimise Design or Product-Related Difficulties
for your Product with our Proven Risk Management for Medical Devices.

Our Risk Management Services at a Glance:

  • Risk assessment and analysis via FMEA: We carry out systematic risk analyses in accordance with ISO 14971 and develop measures to minimise potential hazards.
  • Preparation of the risk management file: We help you to create a complete and traceable risk management file that complies with regulatory requirements (such as ISO 14971).
  • Integration into development processes: We support you in ensuring that risk management becomes an integral part of your product development and the entire product life cycle to ensure adequate handling of potential risks.
  • Post-market risk management: We support you in monitoring your products after market launch in order to recognise potential risks at an early stage and act accordingly.
  • Audits and gap analyses: Our experts review your existing processes and templates and identify potential for optimisation to ensure compliance.

Risk Processes

We adapt existing processes to the conditions of the MDR/FDA in accordance with ISO 14971 or create a completely new process together with you. We pay particular attention to other process areas such as user requirements, usability, clinical evaluation and post-market clinical follow-up (PMCF).

Risk Management Report

The risk management report summarises the results of the entire risk management process. This decision preparation is based on the risk analysis and the defined risk-minimising measures. In addition, we also prepare a risk-benefit analysis or a safety assurance case (SAC) specifically for US products in accordance with FDA 510 [K].

Risk Management Plan

We create a product-specific risk management plan. This includes the definitions of all risk-specific aspects of the corresponding product as well as risk graphs with severity and probability of occurrence with corresponding acceptance criteria.

Risk Analysis

We create a holistic risk analysis. In doing so, we define hazards and hazardous situations, including product-specific potential patient harm. In invenio's risk analysis, we determine the severity of possible patient harm (Harm List), calculate the probability of possible patient harm (Occurrence) and create product-specific risk graphs based on this.

With our in-depth knowledge and many years of experience, we accompany you on the path to safe and successful medical devices. Together, we ensure that your risk management not only fulfils the regulatory requirements, but also offers added value for your company and your customers.

Do you need Support with Risk Management for your Medical Device?
Talk to our Experts:

Leo Zeimetz

Head of Business Unit
Product and System Development

invenio GmbH Engineering Services
Eisenstraße 9
65428 Rüsselsheim am Main

Contact me
P +49 (6142) 899-247
M +49 (172) 6638452

Stephan Drozniak

Managing Director
invenio Healthcare Solutions GmbH

invenio Healthcare Solutions GmbH
Sossenheimer Weg 32
65824 Schwalbach am Taunus

Contact me
P +49 (40) 1806571-51
M +49 (178) 4571675

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Gladly we are at your disposal for any questions! 

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