For beginners and basic needs – Suitable for those of you who need a basic understanding, e.g. working as project leaders, R&D engineers, regulatory managers, quality engineers, sustaining engineers, and/or involved in vigilance investigations and clinical evaluations, as well as beginners within biological evaluations.
What does this course give you?
By developing a basic understanding of biocompatibility-related issues and requirements you can reduce the likelihood of:
- Time-consuming and costly mistakes when choosing materials;
- Having to re-do testing;
- Biocompatibility-related adverse events following material changes;
- Deviations related to material changes at audits; and
- Questions at filing to notified body and authorities.
The course will improve your understanding of biocompatibility to:
- Ensure timely consideration of biocompatibility-related aspects during development;
- Facilitate discussions with those responsible for biological evaluation and test houses; and
- Ease reviewing of biocompatibility-related documentation for regulatory purposes or clinical evaluations.
The course also gives a good introduction to the area if you’ll be working with biological evaluations and you’re new to the field.
All you need to know
The course will be held as virtual training in English, including group discussions and case studies. To facilitate for you, the course will be divided into two sessions, 3h each, on separate days. Each participant will receive a certificate after completion of each session.
Session 1: 3h
- Definition and connection to other processes - risk management, clinical evaluation, quality system process (ISO 14971, ISO 14155, ISO 13485) and Design Development
- ISO 10993-1 general principles and process
- Endpoints of concern and product-specific hazards
- Information needed for biological evaluation
- Overview ISO 10993 remaining standards
- Changes that trigger update of evaluation and case studies
Session 2: 3h
- Basics to think about in material selection
- Dealing with suppliers
- Chemical characterization - Chemical information or chemical analysis?
- Basics to think of when setting up tests with test house
- Key points to be covered due to the EU MDR 2017/745 GSPR
- What notified bodies want to see
- Global aspects
To facilitate for you, the course will be divided into two sessions, 3h each, on separate days. The sessions are not dependent on each other but we highly recommend you to participate in both of them.
Session 1: May 4, 9 am-12 pm or 15-18 pm
Session 2: May 6, 9 am-12 pm or 15-18 pm
Price: 3 000 SEK for one session or 5 000 SEK for both sessions. 25 % local VAT will be added.
If you wish to participate in both sessions you will receive a discount code for session 2 with your receipt when you purchase session 1.
PhD in Polymer Technology with focus on evaluation of migration and degradation behavior of polymeric materials
Lina has 15 years of experience within the medical device industry, working mainly with biological evaluations and toxicological assessments, of which 10 years with focus on breathing gas pathway related devices as part of the development team. Responsibility of evaluation of class I – class III devices for the EU and US markets. In addition, experience within clinical evaluations, environment related requirements, failure evaluations, chemical characterization, and QMS. Active member of the Swedish standardization committee SIS TK340 since 2006 working with the ISO 10993 series as well as active in the work with the standard series for biological evaluations of breathing gas pathways (ISO 18562).
ERT (European Registered Toxicologist), MSc Applied Toxicology, MSc Pharma
Monica has over 20 years of experience in the field of medical devices, mainly within biological evaluation, all phases from a global perspective for class I – class III medical devices, as well as Combination Products. Experience from whole life-cycle risk management, setting up procedures and leading teams and has been involved in different development projects, both within pharma and medical devices. Active member of the Swedish standardization committee SIS TK340 and since 2006 working with the ISO 10993 series. Member of Swedish Toxicology Society, Swedish Academy of Pharmaceutical Sciences and Member of Society of Toxicology (SOT).