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 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 14 webinar sessions, 2,5h each. 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 11 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.
We highly recommend this training series to any health tech stakeholder for gaining 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 and training recordings for the duration of six months. Every individual will also get certificates of attendance according to the sessions attended. Please note: the entire training series is held in English.
1900 € for the full training series of 14 sessions (250 € for one individual session). Three or more attendees from the same organisation are entitled to a 20 % reduction for the full training series. Incubators and regional business units, as well as universities and other institutions, may request unlimited access for their start-ups or researcher teams, students and staff for 7500€/year. (Prices are VAT 0%). Contact email@example.com for group discounts and institutional registrations.
In the Helsinki region, the demand and the need for such a training series were already recognized. Due to the positive feedback received from the cities of Oulu and Tampere, we decided to implement the relatively comprehensive training series also in Helsinki. The investment paid off: 90% of the respondents would recommend the series to their colleagues.
Regulatory compliance is an essential part of the journey and a typical struggle, especially for newcomers. We know from experience that this struggle causes months and years of delays in reaching the market. Thus, it is crucial to give local innovators, and startups access to tools and knowledge that create an early advantage on their demanding regulatory journey.
With Lean Entries and Labquality and their unique service concept, a combination of webinars and Entries, and the digital fast-track tool into the medical device regulations, we give the local innovators a chance to excel in regulatory compliance early on and turn it into their competitive advantage.
Terhi HeikkinenQuality & Regulatory Affairs Manager
Mika SiitonenBusiness Development Manager
Heikki PitkänenCEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
Karri AirolaSenior Expert, Regulations, Quality & Training
”I have more than twenty years of experience in the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).
My responsibilities have also spanned the design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of my career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”
Harinder KorhonenQuality & Regulatory Affairs Manager
Leena RaunioQuality and Regulatory Affairs Manager
Hanna MarttilaManager, Clinical Studies
Jouni KarkinenCEO, Karkinen Consulting
Kirsten SanderARTIMED, Clinical Research Team Lead
Sessions and dates
Compliance as a Business Advantage, 16 March 2023, at 10.00-12.30 EET
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.
Early Development and Management, 21 March 2023, at 10.00-12.30 EET
This session wraps up the must-know issues to consider in the early development of your innovation. How to demonstrate compliance with applicable regulations and how to build up a Quality Management System (QMS) which ensures that devices consistently meet the requirements for safety and performance?
The Core of the Regulatory Requirements, 23 March 2023, at 10.00-12.30 EET
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.
Design Control and the Regulatory Environment, 28 March 2023, at 10.00-12.30 EET
This session reviews the principles of Design Control, starting from feasibility studies all the way to Post-Market Surveillance. A brief look at the roles of the key authorities, certifiers and test laboratories overlooking devices and manufacturers is also given.
Regulatory Essentials of In Vitro Diagnostics, 30 March 2023, at 10.00-12.30 EET
This session is dedicated to essentials for IVD developers, presenting the most important IVD standards, IVD risk classes and regulatory strategies for market entry. Some other IVD specifics are presented as well, such as compiling General Safety and Performance Requirements for IVDs and Performance evaluations.
Medical Device Software, 18 April 2023, at 10.00-12.30 EET
This session is dedicated to Medical Device Software, presenting the essentials of software qualification and classification from both the EU and US perspectives. 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.
Risk Management in Practice, 20 April 2023, at 10.00-12.30 EET
This session takes a practical approach to implementing Risk Management according to the ISO 14971:2019 standard. The different stages of Risk Management, as well as risk evaluation principles, are presented followed by the Benefit-Risk considerations.
FDA, 25 April 2023, at 10.00-12.30 EET
This session gives a basic understanding of the US regulation for medical devices and in vitro diagnostic devices. The regulatory path to the US market and important items related to the FDA, U.S. Food and Drug Administration are reviewed.
Usability and Labelling, 27 April 2023, at 10.00-12.30 EET
This session introduces the essentials of Usability and Labelling. The usability standard IEC 62366, user interface and human factors are explained. The session includes the principles of labelling, such as the requirements for the instructions for use or user manuals, the use of symbols and marketing claims as well as the Unique Device Identifier (UDI).
Biological and Electromedical Safety, 2 May 2023, at 10.00-12.30 EET
This session presents the core requirements for demonstrating the biological and electrical safety of 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 are presented.
Clinical Evaluation in Practice, 4 May 2023, at 10.00-12.30 EET
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 also considered. The requirements for Clinical Investigations as a part of Clinical Evaluation are introduced.
Clinical Investigations in Practice, 9 May 2023, at 10.00-12.30 EET
Conducting a well-designed clinical investigation is undoubtedly the best way to produce information on the safety and performance of a medical device. Clinical investigations or studies can be demanding, and they often require several stakeholders from statisticians to healthcare professionals. Planning of clinical investigation should be part of the early development of a medical device to best comply with the requirements. Practical considerations related to the clinical investigation of medical devices are summarized in this session.
Post-Market Surveillance & Clinical Follow-up, 11 May 2023, at 10.00-12.30 EET
This session gives a basic understanding of the regulation of Post-Market Surveillance (PMS) and the mandatory PMS documentation, such as the Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP).
Person Responsible for Regulatory Compliance, 16 May 2023, at 10.00-12.30 EET
This session summarises the most important elements for a Person Responsible for Regulatory Compliance (PRRC) to consider when carrying out their tasks. Obligations of economic operators, management responsibilities and essential processes for continuous improvement of quality management are revised. This session covers items that are additional to the previous sessions of the Regulatory Essentials in Health Tech training series and completes the qualification for employees assigned with the responsibilities of a PRRC.
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