Regulatory Essentials in Health Tech

This training series provides an efficient introduction to the regulatory essentials to turn regulatory compliance into a business advantage and to avoid the typical pitfalls of the health tech sector. Instead of putting pieces of information together from various courses this training series, in connection to Entries, the Digital Regulatory Runway services, provides the means to save months of time and resources in reaching the global market.

 The Regulatory Essentials in Health Tech training series consists of fourteen 2.5 hour webinar sessions. The sessions cover all stages from the birth of a medical device or in vitro diagnostic innovation to market access and post-market surveillance. Sessions 1 to 4 form the core of the training for any health tech developer and stakeholder from innovators to investors. Sessions 5 to 14 deepen the knowledge by providing real-world examples from the title areas. Dedicated sessions for medical device software and in vitro diagnostics are included. Each session covers ca. 2 hours of training, giving room for questions, answers, and discussion.

TARGET GROUP:
We highly recommend this training series to any health tech stakeholder for gaining the crucial knowledge on regulatory requirements. Health tech start-ups and university innovator teams, as well as new recruits and experienced medical device professionals throughout the field are warmly welcome. All attendees are granted free and unlimited access to Entries, the Digital Regulatory Runways for the duration of a full year.

PRICE:
2400 € for the full training series of 11 sessions (250 € for one individual session). Three or more attendees from the same organisation are entitled to 20 % reduction for the full training series. Incubators and regional business units as well as universities and other institutions may request an unlimited access for their start-ups, researcher teams, students and staff for 7500€/year. (Prices are VAT 0%). Contact koulutus@labquality.fi for group discounts and institutional registrations.

 

TRAINERS:

 


SESSIONS AND DATES:

Session 1 – Compliance as a Business Advantage, 17 March, 2022, at 10.00-12.30 CET
This session introduces the global regulatory landscape for medical devices and presents the areas health tech developers should focus on when bringing new innovations to the markets. Basic terminology, classification rules as well as the importance of a regulatory strategy and regulatory due diligence are presented through examples.


Session 2 – Early Development and Management
, 22 March, 2022, at 10.00-12.30 CET

This session wraps up the must-know issues to consider in early development of your innovation. How to demonstrate the compliance to applicable regulation and how to build up a Quality Management System (QMS) which ensures that devices consistently meet the requirements for safety and performance?


Session 3 – The Core of the Regulatory Requirements, 24 March, 2022, at 10.00-12.30 CET
This session introduces the General Safety and Performance Requirements, which is the heart of the regulation and explains the principles of Clinical Evaluation as well Risk Management for medical devices, both being elementary for fulfilling the manufacturer’s obligations.


Session 4 – Design Control and the Regulatory Environment, 29 March, 2022, at 10.00-12.30 CET
This session reviews the principles of Design Control, starting from feasibility studies all the way to Post-Market Surveillance. A brief look on the roles of the key authorities, certifiers and test laboratories overlooking devices and manufacturers is also given.


Session 5 – Regulatory Essentials of In Vitro Diagnostics, 31 March, 2022, at 10.00-12.30 CET
This session is dedicated to essentials for IVD developers, presenting the most important IVD standards, IVD risk classes and regulatory strategy to market entry. Some other IVD specifics are presented as well, such as compiling General Safety and Performance Requirements for IVDs and addressing Performance Evaluations.


Session 6 – Medical Device Software, 5 April, 2022, at 10.00-12.30 CET
This session is dedicated to Medical Device Software, presenting the essentials of software qualification and classification from both the EU and US perspective. The most relevant standards, IEC 62304 and IEC 82304, for Software Life Cycle requirements are introduced and such topics as artificial intelligence (AI) and cybersecurity are discussed.

 

Session 7 – FDA, 7 April, 2022, at 10.00-12.30 CET
This session gives basic understanding on the US regulation for medical devices and in vitro diagnostic devices. The regulatory path to US market and important items related to the FDA, U.S. Food and Drug Administration are reviewed.

 

Session 8 – Risk Management in Practice, 26 April, 2022, at 10.00-12.30 CET
This session takes a practical approach to implement Risk Management according to the ISO 14971:2019 standard. The different stages of Risk Management as well as risk evaluation principles are presented following on to the Benefit-Risk considerations.


Session 9 – Usability and Labelling
, 28 April, 2022, at 10.00-12.30 CET
This session introduces the essentials for Usability and Labelling. The usability standard IEC 62366, user interface and human factors are explained. The session includes the principles of labeling, such as the requirements for the instructions for use or user manuals, use of symbols and marketing claims as well as the Unique Device Identifier (UDI).


Session 10 – Biological and Electromedical Safety
, 3 May, 2022, at 10.00-12.30 CET
This session presents the core requirements for demonstrating the biological and electrical safety for medical devices. The ISO 10993 series of standards is reviewed from the material characterization to verifying biocompatibility. Likewise, the IEC 60601 series of standards and its application for determining electrical safety is presented.


Session 11 – Clinical Evaluation in Practice
, 5 May, 2022, at 10.00-12.30 CET
This session presents the essentials of a Clinical Evaluation, including the relevant guidelines and the structure of a Clinical Evaluation plan and report and the practices for a Literature Review. Medical device software and in vitro diagnostics (Performance Evaluation) are considered as well. The requirements for a Clinical Investigations as a part of Clinical Evaluation are introduced.


Session 12 – Clinical Investigations in Practice
, 10 May, 2022, at 10.00-12.30 CET


Session 13 –
Post-Market Surveillance & Clinical Follow-up, 12 May, 2022, at 10.00-12.30 CET
This session gives a basic understanding on the requirements every medical device manufacturer must address to maintain compliance throughout the device life cycle. The concepts of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) are explained as enablers of a successful business in the health tech sector.

 

Session 14 – Person Responsible for Regulatory Compliance, 17 May, 2022, at 10.00-12.30 CET

 



BILLING AND CANCELLATION POLICY 

Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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