Get ready for
Post Market Surveillance
As of May 26, 2020, MDR 2020 will apply. Which means that most European Medtech companies (who distribute or produce Medtech products within the EU) must update their certification in order to sell their products within the EU. An important part of MDR 2020 is Post Market Surveillance (PMS).
To facilitate the work of monitoring and reporting what is mentioned about your own products, competitors' products and changes about standards concerning your business area, Omni Observer for Medtech is adapted for companies to easily monitor relevant sources and then with a few keystrokes create a report .
According to industry experts, all companies within Medtech should ensure that processes and tools are fully implemented in 2019 in order to get their new certification in time.
How Hoodin Omni Observer meets the requirements of Post Market Surveillance
Hoodin Omni Observer
Identify opportunities to improve the usability, performance and security of the offer / product
Create coverages that publish clinical research and news about competing products and user content from social media to constantly provide organization with content (articles and videos) about product improvements.
Market monitoring of similar products
Create coverages on databases for both clinical studies and patents to get an overview of changes and news about other related products. You can also create coverages on competitors to retrieve news about their products.
Discover and report trends
By monitoring news sources within Medtech, blogs and social media accounts from researchers who focus on the product's help area and relevant research databases, you get a trend monitoring around the clock.
Update the summary of safety and clinical performance
The ongoing product safety and clinical performance updates are supported in part by coverage created on clinical study databases and a screening to retrieve security discrepancies reported on social media. Combined with internal product tests and evaluation, this requirement is met well.
Update the clinical evaluation
The results from external sources (coverages on databases for clinical studies), combined with internal evaluation, will provide a solid basis for updating clinical evaluation of products.
Identify needs for prevention, corrective or field safety measures
Relevant field security content can be retrieved from social media coverages
(customer and patient posts), discussion forums and other channels.
Update risk assessment, risk management, design and manufacturing information, instructions for use and labeling
The last requirement is mainly internal, where assessments of product properties are made. Omni Observer can contribute with competitor or reference information. However, monitoring digital content with Omni Observer is not enough to meet this requirement. Therefore, internal manual routines are needed instead.