A Collaborative Approach Advancing MDR/ IVDR Implementation
Sponsored by: Borealis
- In Vitro Diagnostics
- Medical Devices
Date: 12 June
Time: 3PM London/ 4PM CET/ 10AM New York
If you would like to register for the 8AM London / 9AM CET / 3PM Singapore, please Click Here.
Together with the value chain, Bormed™ supports implementation of new European regulations, IVDR and MDR
New European legislations, In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR), will come into force sooner rather than later for In Vitro Diagnostic Devices (IVD) and Medical Devices (MD). These new regulations have as an ultimate goal to care for the safety of patients when using medication and when receiving diagnosis.
The IDVR expects an increase from 20% under the current IVD Directive to 80% under the IVD Regulation. This means that devices of many IVD manufacturers, which were not previously certified, will now require certification to keep their products on the market. Hence, time to prepare and get ready for the new European regulations with the right raw materials.
A collaborative approach between IDV/MD manufactures and a reliable raw material supplier becomes important to encounter the changing regulatory market, which may affect your medical and in vitro diagnostics devices. In this changing environment, there will be a need for raw materials that are regulated and documented.
This webinar will bring a compelling case story of a successful collaboration with the IVD value chain, revealing how regulated polyolefin solutions contributed to achieve accurate results in in-vitro diagnostic tests. Accuracy is key in this market as nobody wants to be diagnosed with a false negative/positive result of a contagious disease, because of an unannounced change in the used raw materials.
Furthermore, the webinar will elaborate on the characteristics and properties of a new high flow heterophasic copolymer, recently launched to support developments for medical and in vitro diagnostic devices supporting IVDR and MDR compliance. Being part of the Bormed family of polyolefins, it promises the IVD and MD manufacturers a continuity of supply, change control and a superior product consistency, quality and purity.
With this webinar we will share the learnings from a collaborative approach between the value chain and a reliable raw material supplier supporting applications developments in the wake of the upcoming new European regulations, IVDR and MDR. As well as why the choice of the right partner is as important as the choice of the right material and what the importance of change control is when it comes to the resins you select for your Healthcare applications.
Application Marketing Manager Healthcare, Borealis
Recently, Katinka Brodahl joined the Borealis Healthcare team as Application Marketing Manager, responsible for the positioning of its polyolefin solutions in the medical and in vitro diagnostics markets. Katinka joined Borealis in 2004 and in 2010 its joint venture Borouge.
Katinka gained in both companies a broad experience in communications, hydrocarbons, demand management, marketing communications and group strategy at various locations such as Belgium, Singapore, Abu Dhabi and Vienna. Katinka has a scientific background and a career with extensive market facing activities globally.
Application Development Engineer, Borealis
Faruk Unluuysal joined the Borealis Healthcare team in 2018 as Application Development Engineer, responsible for the development of global healthcare application projects.
Faruk has 19 years extensive international experience of plastics engineering in application development, processing and design within multinational automotive, appliances and chemical companies at various locations such as Japan, Netherlands, Turkey, Belgium and UK.
He has a materials engineering background and is based in Beringen, Belgium.
Healthcare Application Development Engineer, Borealis
Anja Gottschalk joined Borealis in June 2016 as Application Development Engineer Healthcare, responsible for the European and Asian market. She already has more than 20 years of experience in the plastics area in application development, technical service and material management in Automotive, Packaging and Healthcare based on her degree in plastics engineering. She is based in her home office near Frankfurt, Germany.
Key Learning Objectives
- How a collaborative approach supports IDV and MD manufacturers to achieve full compliance with the new regulations
- Explore possibilities of a new regulated high flow heterophasic copolymer for the development of medical and in vitro diagnostic devices
- Experience why change control is as important as any compendial testing
- Packaging engineer
- Material scientist
- Product development
- Research & Development engineer
- Compliance/Regulation manager
- Product stewardship specialist
- Raw material purchasing manager
- Head of packaging
- Head of R&D