"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Medical Device equipment

Biological evaluation of medical devices

Attend 1 or 2 days of your choice:
Part 1 - Introduction to biological evaluation of medical devices
Part 2 - How to perform a biological evaluation,
focus on ISO 10993-1, -17 and -18


Part 1 - Introduction to biological evaluation of medical devices

Part 1 provides you with fundamental knowledge to understand what is needed and why with regards to biological evaluation. One of the requirements, regardless of risk class, is that a biological evaluation report must be presented on final finished device. We have experience from diverse devices reviewed by various NB, US FDA, and other agencies. From time to time we notice mistakes and gaps related to biocompatibility, causing unnecessary delays and expenses.  
- Get to understand the requirements and avoid the most common pitfalls!

Course content:

One-day introduction to biological evaluation where we, among other things, review the following topics:

  • What is the definition of biocompatibility and why is testing needed?
  • ISO 10993 standard series – an overview
  • The relation between ISO 10993 and the risk management standard ISO 14971
  • Which product types and materials are in the scope?
  • What characterizes a “smart” choice of material?
  • The extended scope and safety requirements of hazardous materials/substances in MDR 2017/745
  • Material characterization, typical methods to be used and what kind of information can be achieved?
  • Can animal tests be avoided?
  • What you should consider in the communication with test-house and consultants
  • Guidance on changes that could alter the biological safety of a final device
  • ”Common pitfalls” – avoid the typical mistakes
  • Group discussions with practical examples for exercises

Who should attend:

People working with design and development, project management, regulatory affairs or quality; and people dealing with design changes. The training course provides you with the fundamentals needed to understand what to consider when performing a biological evaluation from choice of materials to the final product.

The course is also suitable for suppliers of materials and components, to facilitate understanding of their customer needs and requirements.

Previous knowledge level:

To be able to grasp and make use of the course content you should have basic knowledge of the medical device regulation with respect to design control.

Part 2 - How to perform a biological evaluation,
focus on ISO 10993-1, -17 and -18

Part 2 offers knowledge about how to plan and conduct a biological evaluation within a risk management process. Focus is on the main part of the standard, ISO 10993-1, but also on part 17 and 18. With the revision of part 1, even more emphasis will be on chemical characterization and towards a risk based approach. The up-coming changes also increase the demand on knowledge. After this course you will have basic knowledge and tools to perform biological evaluation and testing within a risk management process.

Course content:

Second part of the course with focus on the biological evaluation process, including among others:

  • The Biological Evaluation Plan and its parts – a structured way to connect ISO 10993 with risk management and identify appropriate testing strategies
  • The Biological Evaluation Report – key elements to be covered (and what the reviewer wants to see)
  • ISO 10993-1, -17 and -18 - Upcoming changes; what we know today
  • Selection of chemical testing methods for material characterization and the use of results
  • Points to consider when using chemical characterization to reduce the number of animal tests
  • Extractables and Leachables, part 18 – Basic on performance and important points to consider
  • Toxicological assessments, part 17 – Basic on performance and important points to consider
  • Group discussions with practical examples for exercises

Who should attend:

People working with design and development, project management, regulatory affairs or quality.
The course is also suitable for suppliers of materials and components, to facilitate understanding of their customer needs and requirements.

Previous knowledge level:

You should have knowledge/training corresponding to “Part 1- Introduction to biological evaluation of medical devices”.

 

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At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

Bring this course in-house?

Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?

 If so, running the course in-house is probably the best and most cost effective solution.

Make an enquiry

 

Register  

 

Course facts

Course no:
5130 (Part 1)
5131 (Part 2)
Industry:
Medical Device industry

Level:
Basic/Intermediate
Region:
US and EU

Language:
English

Instructors:
Lina Burman    Monica Grekula
Lina Burman and Monica Grekula

Date, location and venue:

Preliminary, april/may 2019,
Copenhagen or Stockholm

This course is offered in-house.
Click here for more info and inquiry form.


Time:
1+1 day
08.30-16.30 (Registration 08.00-08.30)

Price per day (excl. local VAT):
6 330 DKK (€ 850) up to 6 weeks before the course
7 830 DKK (€ 1 050) less than 6 weeks before the course
incl. course material (pdf), lunch and refreshments

SPECIAL OFFER:
Register for both days and get 10% discount

Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.


Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.