Automated Post-Market Surveillance
Comply with Regulatory Requirements
Until recently Post-Market Surveillance activities have mostly been conducted reactively. As an example, companies have been handling the incoming product experiences and complaints. However, today the companies are required to retrieve and analyze information proactively and continuously from several different sources.
In spring 2021 EU’s Medical Device Regulation (EU MDR 2017/745) became fully effective. This also meant new requirements for Post-Market Surveillance activities to be conducted for products in the European market.
Automated Post-Market Surveillance service by MDBS – Allowing you to focus on your core
Fineltec's Medical Device Business Solutions (MDBS) has developed an automated, global monitoring service for Post-Market Surveillance. It is designed to aid companies in medical device industry to comply with the new, stricter post-market surveillance regulations.
The Post-Market Surveillance service automatically monitors any given data sources 24/7, and continuously repeats your inclusion and exclusion criteria.
With the MDBS Post-Market Surveillance service you can trust that your required post-market surveillance activities are being done in a compliant and efficient manner. This allows you to better focus on your core.
New information sources to be utilised
The information sources where the post-market surveillance data is retrieved from, include:
- Scientific literature
- Databases
- Registers
This collected information must be about your own medical device, but also of other similar devices.
According to the new EU MDR (2017/745), it is also required to perform monitoring on the following sources:
- Legislations
- Standards
- Public and social media
These information sources are also included in the Post-Market Surveillance service.
Wider scope of Post-Market Surveillance
The new proactive approach to Post-Market Surveillance enables you to collect and review information of not only your own products. Revealing comparisons can be made with your own device and other similar products available in the market, giving you significantly better insights.
+ 1000 available sources
Post-Market Surveillance Service
- Proactive Real-Time Data Collection and Reporting as a Managed Service
- Scientific Literature
- Regulatory Requirement
- Adverse Events
- Authority Publications and Recommendations
- Standards
- Public and Social Media
Post-Market Surveillance Licence
- Proactive Real-Time Data Collection and Reporting license, for self-managed surveillance
- Scientific Literature
- Regulatory Requirement
- Adverse Events
- Authority Publications and Recommendations
- Standards
- Public and Social Media
You can order automated Post-Market Surveillance as a Managed Service. Alternatively you can purchase a License and perform the surveillance and report generation yourself.
Managed Service is ideal for small and mid-size companies without dedicated post-market surveillance functions, whereas self-management license is a great choice for larger companies with existing post-market departments.
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Our mission is to provide high quality services with a personal touch. We cooperate closely with our customers, helping them to grow together with a reliable partner. We understand our customers’ needs and assist them to be one step ahead on the fast-moving market.
- Established in 1993
- Nearly 100 employees
- Production facility of 4000 m2
- 17 million Euro turnover
- EU location
Our clients include
