"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Requirements to place Medical Device Software and Health Software on the market
This training covers the regulations and standards applicable to Medical Device Software: mobile medical apps, web apps, connected objects, and/or standalone software for diagnosis or planning.
It also covers Health Software, not regulated as medical devices like software managing patient information.
During this training, you will learn:
- how to qualify and classify standalone software
- what regulations are applicable to your software: CE marking, FDA
- how to apply standards related to software : IEC 82304-1, and IEC 62304
- how to coordinate ISO 13485 and ISO 14971 with IEC 82304-1, and IEC 62304
- How to classify and quality software:
- Worldwide overview of Regulations
- The CE Mark and the CE Directives
- The 21 CFR and FDA guidances
- Application to software medical devices
- ISO and IEC standards for software medical devices
- Paths to Clearance and CE mark
- IEC 82304-1
- Why IEC 82304-1, Scope
- Relationships with other standards: ISO 13485, ISO 14971, IEC 62304
- Software Requirements
- Software Validation
- Requirements on Instructions for Use
- Requirements on Post-market
- IEC 62304
- History of software standards in medical devices.
- Terms & definitions
- General Requirements
- Software Development Process
- Software Risk Management
- Software Maintenance
Who should attend:
Medical Device professionals who are involved in the following areas:
- Development of medical devices containing software, and software as stand alone medical devices
- Risk assessment of software based product
- QA/RA managers within companies with Medical Device Software or Health Software development
- Purchasers involved in the purchase of Software development from subcontractors
- Project managers handling sub-contracted Software development
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
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.
Date, location and venue:
11-12 June 2019, Copenhagen
(Entrance from Kvægtorvsgade)
This course is also offered in-house.
Click here for more info and inquiry form.
8.30-16.30 (Registration 08.00-08.30 day 1)
Price (excl. local VAT):
Register by 30 April: 13 750 DKK (€ 1850) - Save 1 500 DKK
From 1 May: 15 750 DKK (€ 2050)
Incl. course material (pdf), lunch and refreshments
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.
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.
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 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.