Industries.
Medical Devices Consulting.
Our specialized medical technology consulting services guide you safely through regulatory requirements and complex product developments.
Complex?
We support you in coping with increasing regulatory requirements - quickly, efficiently and in compliance with the rules.
Prone to risk?
Minimize risks through reliable processes and robust quality management in every project phase.
Innovative?
Accelerate the market launch of innovative medical devices - from development through clinical evaluation to successful market launch.
Optimize your medical device processes!
Medizintechnik Consulting - Your partner for compliance, quality & efficiency.
Our specialized consulting services help you to reliably meet regulatory requirements and efficiently bring your medical devices to market.
The medical technology industry faces complex challenges such as increasing regulatory requirements due to the European Medical Device Regulation(MDR), high quality standards in accordance with ISO 13485 and demanding clinical requirements in accordance with ISO 14155. Our experts support you throughout the entire product life cycle - from product development and approval to post-market surveillance.
With our experience in regulatory affairs, we provide you with comprehensive support in the preparation of regulatory-compliant technical documentation, clinical evaluations and the efficient management of approval procedures worldwide. We also develop strategies for MDR compliance and successful cooperation with health authorities.
Together with you, we implement effective quality management systems, optimize production processes and carry out targeted validations. Our aim is to sustainably improve your processes, ensure regulatory compliance and accelerate the market launch of your medical devices through customized solutions.
Comprehensive consulting services for medical devices.
Our tailor-made services cover all key areas of medical technology and IVD, from compliance with regulatory requirements to process optimization.
Regulatory Affairs & MDR Compliance.
- Strategic advice on EU MDR compliance for new & existing products
- Creation & updating of technical documentation in accordance with MDR
- Support with certifications by notified bodies
- Regulatory strategy for global market approvals (FDA 510(k), PMA, CE marking)
- Compliance advice on Person Responsible for Regulatory Compliance (PRRC)
Quality management & process optimization.
- Implementation & auditing of ISO 13485-compliant QMS
- Introduction of risk management in accordance with ISO 14971 to identify and minimize product and process risks
- CAPA management for efficient processing of quality problems & corrective measures
- Conducting mock audits for MDR or FDA inspection preparation
- Support with supplier qualification & audits
Clinical evaluation & market surveillance.
- Preparation of Clinical Evaluation Reports (CER) in accordance with MDR & ISO 14155
- Performance evaluation for in-vitro diagnostics (IVDR)
- Support in the implementation of Post-Market Clinical Follow-ups (PMCF)
- Development of strategies for clinical follow-up & market data analysis
- Implementation of regulatory requirements for Software as a Medical Device (SaMD)
Product development & usability engineering.
- Design control & documentation in accordance with FDA and MDR requirements
- Verification & validation (V&V) of medical devices
- Usability engineering in accordance with IEC 62366 for optimized user-friendliness
- Integration of regulatory requirements in research & development
Discover our Life Sciences expertise.
Research and Development and Engineering
We support your product development with innovative solutions for design, validation and implementation.
Clinical and Medical Affairs
We offer comprehensive expertise in study management, risk assessment and market surveillance.
Quality Management and Operational Excellence
We optimize your processes to increase efficiency and ensure the highest quality standards.
Business Data Solutions & IT Services
We create sustainable strategies and optimize your IT processes for maximum efficiency.
Manufacturing and Supply Chain Management
We develop solutions for efficient production and smooth supply chains.
Regulatory and Compliance
We navigate you safely through complex regulatory requirements and audits.
Our successes in medical device consulting.
Our successful medical device projects show how customized solutions in the areas of regulatory affairs, quality management and R&D make the difference.
Introduction of a global regulatory compliance program for a medical technology company
Optimization of clinical evaluation processes for a medical technology company
Improvement of process quality and CAPA management for a medical technology company.
Development of a scalable risk management system for a growing medical technology company
Challenge.
A fast-growing medical technology company needed a scalable risk management system to meet MDR requirements while supporting future business growth. The aim was to develop a flexible solution that would both cover the regulatory requirements and enable future growth.
Measures.
- Introduction of a scalable risk management system that seamlessly integrates design control, verification and validation.
- Development of processes for the continuous review and adjustment of the risk management system in line with the company's development.
- Implementation of risk management strategies to proactively identify and mitigate risks in all development phases.
Results.
- Successful implementation of a flexible and scalable risk management system.
- Ensuring MDR compliance and supporting the future growth of the company.
- Improved risk assessment and faster adaptation to new regulatory requirements.
Success.
The company was able to future-proof its processes and comply with MDR requirements while preparing for further growth.
Make your medical device projects future-proof.
Our medical device consulting services at a glance.
Our comprehensive consulting services cover all the key areas required for success in the medical technology industry - from product development and approval to market surveillance.
Our experts develop customized strategies to ensure the approval of your medical devices worldwide. We support you with MDR/IVDR compliance, prepare and review technical documentation in accordance with CE marking requirements and support your FDA approvals in accordance with US FDA requirements. We also help you implement a risk management system in accordance with ISO 14971 and support you in appointing the Person Responsible for Regulatory Compliance (PRRC).
In the area of Clinical Affairs, we support you in conducting clinical evaluations and complying with international standards such as ISO 14155 (clinical studies) and ISO 20916 (IVD performance evaluation). We prepare Clinical Evaluation Reports (CERs) in accordance with MDR requirements, Performance Evaluation Reports (PERs) for IVDs and ensure that your medical devices meet the highest clinical requirements. In addition, we offer comprehensive support for Post-Market Clinical Follow-ups (PMCF) according to EU MDR guidelines.
We support you in the implementation and optimization of a robust quality management system (QMS) in accordance with ISO 13485. Our experts ensure that your processes are CAPA-compliant (Corrective and Preventive Actions) and that your company is optimally prepared for audits and inspections by health authorities. Our expertise in the area of Post-Market Surveillance (PMS) ensures that you meet regulatory requirements even after market launch.
Our research & development and engineering services cover all aspects of your product development. We offer support with design control processes, including verification and validation, as well as with the implementation of the IEC 62366 standard for usability engineering. Our experts will also assist you with the assessment of biocompatibility in accordance with ISO 10993 and support you with regulatory changes (design changes). In this way, we ensure that your products are innovative, safe and fully compliant with regulatory requirements.
Get to know our experts.
Get in touch with our medical technology experts.
Dr. Jennifer Neff
Head of Medical Device
Dr. Julia Beck
Head of MedTech Sales
