REGULATORY NAVIGATION PROGRAM – CLINICAL EVALUATION IN PRACTICE

Regulatory compliance is an essential part of the journey when developing safe healthtech solutions for the European and global markets! It’s a common struggle, entering this new line of business and causes months and years of unnecessary delays in reaching the market.

This series of educational sessions combined with the interactive tool Entries and One-on-One sessions with Regulatory Experts, serves to navigate faster, minimize risk and overcome some of the hurdles that you commonly face while developing safe health tech solutions for the European and global market! (The One-on-one sessions are not part of this offer at this point).

Please register to the regulatory navigation program!

OVERVIEW 

Session 1-4, that has been previously delivered gives vital and global overview to all people involved in the introduction of new health tech solutions and all stakeholders interested in saving months in time-to-market of health tech innovations and to avoid typical dead-ends due to non-compliance. Founders, investors, advisors, market and salespeople, developers, researchers all benefit from session 1 and session 2-4 mainly address business advisors and start-up founders, but other target groups may have interest and find these sessions very valuable. You find the previous recordings on Slack here.

Sessions to follow, see dates below.

By attending theses more in-depth sessions you will gain important and more specific information in different areas.

Educational session dates:

• Wed 3 Feb at 9-11.30 CET – MEDICAL DEVICE SOFTWARE, with Heikki Pitkänen and Ilona Santavaara

• Tue 9 Feb at 9-11.30 CET – RISK MANAGEMENT IN PRACTICE, with Leena Raunio

• Wed 17 Feb at 9-11.30 CET – USABILITY AND LABELLING, with Ilona Santavaara and Heikki Pitkänen

• Tue 23 Feb 9-11.30 CET – BIOLOGICAL AND ELECTRICAL SAFETY, with Karri Airola and Ilona Santavaara

• Thu 11 March 9-11.30 CET – CLINICAL EVALUATION IN PRACTICE, with Ilona Santavaara

• Thu 18 March 9-11.30 CET – POST-MARKET SURVEILLANCE AND POST MARKET CLINICAL FOLLOW-UP, with Heikki Pitkänen or Karri Airola

At the end of the training series, you will get a certificate based on the sessions you attended.

With the online tool Entries you can match your solution to the regulatory framework of EU in a minute and get instant access to applicable documentation and improve your knowledge.

This service is provided by Lean Entries in cooperation with HealthTech Nordic for the purpose of supporting the success of Nordic health tech solutions and improving world health.

Following the series of session, you will get a broad understanding of the area but also but also deeper knowledge into topics such as hardware, software and post-market. One-on-one sessions and solution specific support is not included in this offer at this point in time.

ACCESSIBILITY AND PRICE 

Free of charge for HealthTech Nordic:

• Startup Members of HealthTech Nordic (inside ÖKS region): Educational sessions tool is Free of charge
• Startups members of HealthTech Nordic (outside ÖKS region): Educational sessions free and tool at a reduced price
• Founding partners of HealthTech Nordic: Educational sessions tool is Free of charge for all personnel
• Associated partners to HealthTech Nordic (and other institutions and organisations): Read more about the offer under the heading “Tag-along option for other institutions in the region” below.

DETAILS ABOUT EACH SESSION

MEDICAL DEVICE SOFTWARE

Target group: Start-up founders and teams from development to international scaling working on software that is utilized in a health care setting.

Value for target group: Understanding the rules to qualify and classify software as a medical device. Learning how to control the software design according to applicable requirements throughout the software life cycle.

RISK MANAGEMENT IN PRACTICE

Target group: Medica device start-up founders and teams from development to international scaling.

Value for target group: Risk Management is one of the core regulatory requirements for all medical device manufacturers throughout the device life cycle. Learning the basics provides crucial knowledge for all health tech stakeholders.

USABILITY AND LABELLING

Target group: Medical device start-up founders and teams from development to international scaling.

Value for target group: Usability and Labelling are essential regulatory concepts and must be mastered by all medical device manufacturers. Especially the usability engineering process provides opportunities to excel on the health tech market.

BIOLOGICAL AND ELECTRICAL SAFETY

Target group: Medical device start-up founders and teams from development to international scaling working on hardware and electrical medical devices.

Value for target group: Biological and Electrical Safety are essential regulatory concepts and must be mastered by medical device manufacturers, where applicable for their devices.

CLINICAL EVALUATION IN PRACTICE

Target group: Medical device start-up founders and teams from development to international scaling.

Value for target group: Clinical Evaluation is one of the core regulatory requirements for all medical device manufacturers throughout the device life cycle. Learning the basics provides crucial knowledge for all health tech stakeholders.

POST-MARKET SURVEILLANCE AND POST-MARKET CLINICAL FOLLOW-UP

Target group: Medical device start-up founders and teams from development to international scaling.

Value for target group: Post Market Surveillance is one of the core regulatory requirements for all medical device manufacturers throughout the device life cycle and requires planning already during the development stage.

ENTRIES – INTERACTIVE REGULATORY NAVIGATION TOOL
Use the Entries tool for the minute and complete Qualification and Classification of medical devices according to the MDR and the IVDR and walk through the central regulatory consequences on the EU market. At any time you can go back and alter your answers to see what difference it makes to the regulatory framework. To request access to the tool please email Susanne Hertzberg.

ONE-ON-ONE SESSIONS – SOLUTION SPECIFIC SUPPORT

Not included in this offer. Availability on-demand through the Business Advisors of HealthTech Nordic for Startups members of HealthTech Nordic inside ÖKS region.

TAG-ALONG OPTION FOR OTHER INSTITUTIONS IN THE REGION

Along with providing the training program to HealthTech Nordic member startups and the personnel of HealthTech Nordic Partners, we offer the opportunity for each HealthTech Nordic Partner to invite the personnel, innovators and students of their associated institutions (universities, hospitals, incubators, technology associations etc.) to join the same educational sessions for the price of 750 €/session/institution without limitations in the number of attendees. This offer aims at generating a level baseline of knowledge across the health tech field regarding global regulatory essentials.

In addition, we offer the opportunity for each HealthTech Nordic Partner to invite the same institutions to take benefit of the Entries tool for the price of 1.500 €/year/institution. The same applies also to each HealthTech Nordic Associated Partner and their associated institutions. There are no limitations on the number of subscribers from each institution.

The service will be invoiced from LeanEntries (not HealthTech Nordic). Any details and specific requests may be negotiated with Lean Entries.

This tag-along option comes with a request, that each of the HealthTech Nordic Partners and associated partners will grant permission to use their organisation’s logo and website link to be published on the Lean Entries website as our client.