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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 14 on-demand webinar sessions, 1,5-2 hours 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 1,5-2 hours of training, giving room for questions, answers, and discussion. The digital Entries services complete the learning experience and provide hands-on tools to get started with regulatory compliance.

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Target group

We highly recommend this training series to any health tech stakeholder to gain crucial knowledge on regulatory requirements. Health tech start-ups, university innovator teams, new recruits, and experienced medical device professionals throughout the field are warmly welcome.

All attendees are granted free and unlimited access to the Entries regulatory runway module ’New EU Medical Device Regulations’ and training recordings for 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.

Price

1900€ for the entire training series of 14 on-demand sessions (250€ for one individual session). Three or more attendees from the same organization are entitled to a 20% reduction for the entire training series. Incubators, regional business units, science parks, universities, and other institutions are welcome to request a fixed yearly price that covers their start-ups or researcher-to-business teams, students, and staff. Contact koulutus@labquality.fi for group discounts and institutional registrations.

Customer testimonials

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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.

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Suvi Hänninen
Economic Development, City of Helsinki
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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.

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Juho Väisänen
Program Manager, Innovation Servies Of Tampere University and Development Manager Of SPARK Finland
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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.

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Tommi Uitti
Startup Ecosystem Community Manager at Business Tampere

On-demand sessions

Compliance as a Business Advantage

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

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

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

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.

Medical Device Software

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

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.

Regulatory Essentials of In Vitro Diagnostics

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.

FDA

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

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

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

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

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

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

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.

Trainers

Terhi Heikkinen
Terhi Heikkinen
Quality & Regulatory Affairs Manager
terhi.heikkinen@labquality.com
Terhi is a medical device professional with over 20 years of experience in product development, quality, and regulatory affairs as well as quality management system development. She has held responsibilities for building or improving QMS and technical documentation to enable QMS certification or product registration. Terhi has an extensive experience in project design control, risk management, verification and validation activities, CE and 510(k) submissions, and ISO 13485, EU MDR, EU IVDR, and FDA quality system requirements and their implementation.
Mika Siitonen
Mika Siitonen
Head of Digital Health
mika.siitonen@labquality.com
Mika is a business-orientated expert in software-driven medical devices and product registrations with over 15 years of experience in project management, R&D, and testing from the medical device field as well as other industries. He has a broad understanding of design control, testing methodology and its development, data visualization and statistical analysis. In his duties, Mika has specialized in software registrations and the new medical device regulation on software products.
Heikki Pitkänen
Heikki Pitkänen
CEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
heikki.pitkanen@labquality.com
”I have more than 20 years of experience in the health tech field including responsibilities in product development as well as regulatory and quality-related positions. I have worked previously at SGS as a site manager providing Medical Device manufacturers with Notified Body, accredited test lab and training services for worldwide market access. I have participated in international standardization and in the CEN-CENELEC Advisory Board for Healthcare Standards."
Karri Airola
Karri Airola
Senior Expert, Regulations, Quality & Training
karri.airola@labquality.com

”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.”

Ilona Santavaara
Ilona Santavaara
Senior Expert, Regulations & Quality
ilona.santavaara@labquality.com
”I have worked in regulatory compliance positions for 15 years. Prior to stepping into the Medical Device field, I held responsibilities in consumer electronics and environmental and material compliance and continue to advise manufacturers on those topics. For the past seven years, I have been guiding various health tech companies with Medical Device regulations. My experience ranges from the compliance of artificial intelligence (AI) medical software to hands-on clinical evaluation, and from setting up and auditing ISO 13485 compliant quality management systems to enabling the international market access for several types of health technology.”
Leena Raunio
Leena Raunio
Quality and Regulatory Affairs Manager
leena.raunio@labquality.com
”I’m an experienced regulatory affairs and quality assurance professional who has worked for a number of Medical Device manufacturers, ranging from biodegradable orthopaedic implants to medical software for the US, EU and many other markets. I hold experience from senior managerial roles in multinational regulatory and quality-related positions and I have supported many Medical Device manufacturers and other economic operators as a regulatory consultant throughout my career that spans two decades.”
Hanna Marttila
Hanna Marttila
Manager, Clinical Studies
hanna.marttila@labquality.com
"I hold more than 25 years of experience within heavily regulated life science businesses both in the public and private sectors. I have strong expertise in clinical trials (drugs and medical devices) both in commercial and academic settings in various positions. My working experience in medical device regulatory affairs with worldwide submissions and sales approvals has given me a deep understanding of business practices, laws and regulations."
Kirsten Sander
Kirsten Sander
ARTIMED, Clinical Research Team Lead
kirsten.sander@labquality.com
Kirsten Sander, MSc Biology, is the Clinical Research Team Lead for Labquality’s subsidiary Artimed Medical Consulting GmbH in Germany. She has been working in clinical research for more than 10 years, with experience in medical and scientific writing, monitoring, and project management. She has in-depth knowledge of regulatory requirements for clinical investigations (EU MDR, MDCG, ISO 14155, German MPDG), clinical evaluations, and post-market clinical follow-ups.