Expertise.
Medical Device Vigilance.
Our vigilance services ensure the safety and regulatory compliance of your medical devices.
Secure?
Is the safety of your medical devices continuously monitored and documented?
Efficient?
Do you have all the regulatory requirements for the vigilance of medical devices fully under control?
Compliant?
Are your processes ready for reporting incidents to the relevant authorities?
Ensure the safety of your medical devices with our vigilance services.
Medical Device Vigilance - Ensuring product safety and compliance with regulatory requirements.
Our vigilance services for medical devices ensure continuous monitoring of product safety and compliance with all regulatory requirements.
The vigilance of medical devices ensures that potential risks and safety-relevant events are identified at an early stage and reported to the relevant authorities. Our experts support you in implementing the necessary processes to monitor the safety of your products throughout their entire life cycle. We ensure that all reports are submitted on time and that you are prepared for inspections and audits at all times.
We support you with:
- Monitoring of medical devices: We monitor the safety of your products and report incidents to the authorities.
- Reporting and compliance: Preparation and timely submission of vigilance reports in accordance with applicable regulations.
- Communication with authorities: We support you in communicating with the relevant authorities and ensure compliance with all requirements.
Our Medical Device Vigilance Services at a glance.
Our Medical Device Vigilance services offer you comprehensive support in monitoring and reporting on product safety and compliance with regulatory requirements.
Monitoring of medical devices.
- Regular monitoring of your medical devices for safety-relevant events
- Analysis and reporting of incidents and security problems
- Ensuring compliance with all vigilance requirements for medical devices
Reporting and compliance.
- Preparation of reports on incidents and security-relevant events
- Timely submission to national and international authorities
- Support in preparing for audits and inspections
Communication with authorities.
- Direct contact for the relevant authorities in the event of incidents
- Support with official audits and inspections
- Advice on adapting to new regulatory requirements
Our success stories in medical device vigilance.
Find out how we have helped medical device companies optimize their vigilance processes and ensure product safety.
Optimization of the vigilance system for a medical technology company
Introduction of a vigilance system for a growing medical technology company
Preparation of technical specifications for a biotechnology company
Challenge.
A biotechnology company needed technical specifications for a new product that was in the development phase to meet regulatory requirements.Measures.
- Preparation of detailed technical specifications for regulatory submission
- Close cooperation with the R&D team to ensure that all technical details are accurately represented
- Ensuring compliance with international standards and regulations
Results.
- Successful submission of the specifications to the competent authorities
- Shorter development time thanks to clear and comprehensive specifications
- Improved communication between the development teams
Success.
The company was able to submit the product for official approval on time and make the development process more efficient.Ensure the safety of your medical devices.
Our Medical Device Vigilance portfolio.
Our medical device vigilance services provide you with comprehensive support in monitoring and ensuring product safety and compliance with all regulatory requirements.
We continuously monitor the safety of your medical devices and ensure that safety-relevant incidents are detected and reported in good time. In doing so, we closely follow the legal requirements, such as those of the Federal Institute for Drugs and Medical Devices (BfArM) and international authorities such as the FDA in the USA. Our experts also support you in the selection and implementation of suitable software solutions to make your vigilance processes digital and efficient.
Our experienced specialists prepare all the necessary vigilance reports for you in accordance with the regulatory requirements of the EU Medical Device Regulation (MDR), the IVDR and national provisions such as the Medical Device Law Implementation Act (MPDG). We ensure that these reports are submitted to the relevant national and international authorities on time and actively support you in the preparation and implementation of official audits, inspections or reviews by notified bodies such as TÜV SÜD.
Our experts are your direct contacts for communication with the relevant authorities. We take care of professional and timely communication on safety-related incidents for you and support you with regulatory adjustments to new requirements, such as those arising from current guidelines from the Medical Device Coordination Group (MDCG) or new specifications from Swissmedic. In this way, we ensure that your processes are always up to date and that all requirements are reliably met.
With regular and individually tailored training courses, we provide your employees with targeted, up-to-date knowledge about regulatory requirements, vigilance processes and reporting obligations. Our training courses always take into account the latest regulatory developments, including those based on official recommendations and guidelines from the European Commission.
We support you in the selection and implementation of suitable digital vigilance systems that are specifically tailored to the regulatory requirements of your medical devices. Our experts will accompany you from the initial analysis to the complete integration of a solution that enables efficient recording, evaluation and reporting of safety-relevant data.
Ensure product safety and meet all regulatory requirements.
Related topics to the monitoring of medical devices.
These supplementary services support you in efficiently monitoring and reporting incidents involving medical devices:
