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Regulatory Essentials in Health Tech

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The Regulatory Essentials in Health Tech training series is a perfect choice for health technology start-ups who wish to receive a condensed but still comprehensive review of the applicable regulations and their effect on business. Moreover, the training series also fits those who have worked in the sector but would like to update their knowledge of regulations.

Inhalt

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. Read the complete Regulatory Essentials in Health Tech training description.
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Trainer

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
Senior Advisor, Clinical Studies
hanna.marttila@labquality.com

Hanna Marttila is the Senior Advisor for Clinical Studies in Labquality's CRO business. She has over 25 years of experience in the life sciences sector, both in the public and private sectors. Hanna has strong expertise in clinical studies (drugs and medical devices) in both commercial and academic settings, where she has held various roles. Her work experience in regulatory roles related to medical devices and in drafting international marketing authorization applications has given her a comprehensive understanding of business practices and the application of laws and regulations.

Kirsten Sander
Kirsten Sander
ARTIMED, Clinical Research Team Lead
kirsten.sander@labquality.com
Kirsten Sander, MSc Biologie, ist die Leiterin des klinischen Forschungsteams der Labquality Tochtergesellschaft Artimed Medical Consulting GmbH in Deutschland. Sie ist seit mehr als 10 Jahren in der klinischen Forschung tätig und verfügt über Erfahrung im medizinischen und wissenschaftlichen Schreiben, Monitoring und Projektmanagement. Sie verfügt über fundierte Kenntnisse der regulatorischen Anforderungen klinischer Prüfungen (EU MDR, MDCG, ISO 14155, deutsche MPDG), klinischer Bewertungen und klinischer Nachbeobachtungen nach dem Inverkehrbringen (PMCF).

Zielgruppe

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, 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 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.

Nach diesem Training

Will have saved months’ worth of work in reaching the market.

The Regulatory Essentials in Health Tech training series is tailored to turn regulatory compliance into a business advantage for health tech companies and to avoid the typical pitfalls of the sector.

The training series is complemented with Entries, the Digital Regulatory Runway service, to navigate the basic regulatory requirements in minutes.

Hinweis

1900 € for the entire training series of 14 on-demand sessions (250 € for one individual on-demand session). Three or more attendees from the same organization are entitled to a 20 % reduction for the entire training series. Incubators, regional business units, 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 koulutus@labquality.fi for group discounts and institutional registrations.

RECHNUNGS- UND STORNIERUNGSBEDINGUNGEN

Lesen Sie hier die Abrechnungs- und Stornierungsbedingungen für Online-Schulungen.

Die Teilnahme an der Schulung kann zwei Wochen (14 Tage) vor der Veranstaltung kostenfrei storniert werden. Bei Stornierungen, die danach erfolgen, berechnen wir 50 % der Teilnahmegebühr, bei Stornierungen, die eine Woche vor der Veranstaltung erfolgen, berechnen wir 100 % der Teilnahmegebühr.

Stornierungen erfolgen immer schriftlich an: koulutus@labquality.fi.  
Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@labquality.fi meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.

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