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Network. Learn. Grow


This event offers a unique opportunity to network, learn from peers, and grow with new strategies to elevate your company to the next level.

Details


Time: 9:00pm - 5:30pm 

Location: Copenhagen, DK 

Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S

Agenda 


9:00 AM: ARRIVAL & NETWORKING

Enjoy networking with your  MedTech peers!

10:00 AM: WELCOME
10:15 AM: EU MDR: Insights & Success Strategies for Market Entry

In this session, the panelists will dive into the current challenges of MDR compliance, explore the impact of the regulation on market entry strategies, and discuss the nuances of navigating the certification process with Notified Bodies. There will be an opportunity for live Q&A.

Featuring Bassil Akra, Enrico Perfler, Helene Gustafsson, Ralf Gansel, & Etienne Nichols

11:00 AM: NETWORKING BREAK
11:15 AM: BREAKOUT SESSIONS 
  • QA/RA:
    Reflections: Common Mistakes When Bringing Medical Devices to Market
    This fast paced, interactive session will distil experience from hundreds of organisations and the most common mistakes and misunderstandings in design controls, risk management, and requirements engineering and include useful hints and tips on how to avoid them and be efficient in medical device product development. | Peter Sebelius, Medical Device HQ & authoring teams for ISO 13485 and ISO 14971
  • Clinical: Achieving MDR Certification for Legacy Devices
    This session will outline the necessary steps for legacy medical devices to meet new MDR standards, starting with a gap assessment in clinical data. It will also detail the creation of a clinical evaluation plan and strategies for engaging with regulatory authorities to streamline the approval process.
    | Helene Quie, CEO at Qmed Consulting

 
12:00 PM: LUNCH & NETWORKING
1:15 PM: Going to the U.S.? Navigating regulatory requirements

Details coming soon!

Featuring Karandeep Singh Badwal, Anette Kristiansen, Edwin Lindsay, and Etienne Nichols

2:00 PM: NETWORKING BREAK
2:15 PM: BREAKOUT SESSIONS
  • QA/RA:  Planning: A Strategic Approach to Compliant Medical Device Design
    The talk will define a systematic approach used in early development of new devices to target compliance efficiently. The device's requirements shall be identified and transformed into verifiable design inputs followed by quality assurance plans, and overall verification strategy. Risk of missing requirements not planned shall be addressed as product compliance risk, and business risk. | Bostjan Barbis, Head of Solution Delivery Europe, Rook Quality Systems

  • Clinical: Strategies for EU Clinical Evidence Generation
    Achieving compliance with EU MDR 2017/745 is still a challenge for many manufacturers. One of the main topics leading to continuous round of questions and challenges with Notified Bodies is the clinical evaluation report. During this session, we will discuss the various possible pathways to achieve EU MDR compliance by addressing sufficiency of clinical evidence for legacy or new devices, methods to fulfill PMS & PMCF, etc.
    | Bassil Akra, CEO at Akra Team
3:00: NETWORKING BREAK
3:15 PM: THE GLOBAL MEDICAL DEVICE PODCAST: LIVE | True Quality stories in MedTech

Hear the personal narratives of MedTech leaders who offer real-world, actionable best practices for industry professionals towards future innovation and implementation of True Quality medical devices.

Featuring Marcus Carstensen, Morven Shearlaw, & Etienne Nichols

4:00 PM: NETWORKING, HORS D'OEUVRES, & DRINKS 
5:30 PM: EVENT ENDS

Here is what you can expect:

Networking-01-01

NETWORKING

NO icebreakers, NO name games, just MedTech professionals who are excited to network with peers and enjoy our specialty drinks and hor d'oeuvres.

Panel-01

PANEL DISCUSSIONs

Morning and afternoon panels where medical device leaders will share strategies, key takeaways, and best practices on market entry in the EU and United States.

Podcast-01

Live Podcast

Experience a live recording of the Global Medical Device Podcast where Etienne Nichols sits down with some of the best minds in Medtech to get actionable insider knowledge.

ABOUT THE ROADSHOW

The Greenlight Guru True Quality Roadshow brings together MedTech leaders in quality, regulatory, clinical, and product development to connect with their local MedTech community, learn exclusive industry insights, and find inspiration to continue improving the quality of life.

Join us (for free!) to connect with expert speakers, attend engaging workshops, and enjoy ample networking that is sure to deliver important connections and learnings just for MedTech leaders in this new era of work.

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OUR SPONSORS

Interested in joining them? There's still some sponsorship options available. Learn more here.

compliance solutions

 

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Guest Speakers

Interested in speaking at a True Quality Roadshow? Let us know!

 

Bassil Akra

Bassil Akra

CEO | AKRA TEAM GmbH

Bassil Akra

CEO | AKRA TEAM GmbH

Experience in R&D, Manufacturing and Testing, Conformity Assessment Activities as a Notified Body Reviewer and Auditor, and finally preparation of Standards and Guidance Documents. 

I support medical device and in-vitro diagnostic device manufacturers preparing and executing a compliant regulatory, clinical and quality strategy in the EU. I can speak the language of legislators, notified bodies and manufacturers. Let´s connect: bassil.akra@akrateam.com

Karandeep

Karandeep Singh Badwal

Founder | QRA Medical

Karandeep Singh Badwal

Founder | QRA Medical

Do you need help legally bringing your medical device to market in the UK, EU or USA? Feel free to send me a message to see how we can work together on achieving this 📧

Using my extensive knowledge of scientific, legal and business issues acquired throughout different aspects of my work, my main role is to ensure the appropriate licensing, marketing and legal compliance of medical devices to make sure that they reach the end consumer safely.

I see myself as a crucial link between the industry and the general public; as their bridge of trust to ensure that the medical products that they use are of a high quality standard and meet every guideline there is.

Moving forward, I am always willing to meet people from both the medical and healthcare industry to share their experiences and stories. If you take an interest to what I do or wish to contact me for business and/or other opportunities, please feel free to connect with me

Book a Microconsulting call with me: https://calendly.com/karandeepbadwal/microconsulting

Functional Areas of Focus:
- Medical Devices (ISO 13485, ISO 14971, MDR, Quality Management Systems, Technical File Remediation, ISO 11607, ISO 14644, IQ OQ, PQ, FDA CFR 21, GMP, 510k, IEC 62304, IEC 82304, Complaint Handling, CAPA, Sterilisation, Software Validation, Computer System Validation CSV, eQMS, Article 10(9)
- Regulatory Affairs (RA)
- Quality Assurance (QA/QC)
- Medtech (SaMD, Digital Health, Artificial Intelligence/AI, Machine Learning)
- PRRC (Person Responsible for Regulatory Compliance)
- UKRP (UK Responsible Person)
- eQMS (Qualio, Greenlight Guru, JIRA, Atlassian, G Suite, Confluence, Mastercontrol)
- Certified ISO 13485 QMS Auditor (CQI/IRCA)
- Certified EU MDR Practitioner (CQI/IRCA)
- UKCA, CE, FDA, 510k, PMA, De Novo

My Content:
- How to build an ISO 13485 Quality Management System: Tinyurl.com/yagnzxm7
- ISO 13485 or ISO 9001 Quality Management Systems: Tinyurl.com/yavjg6kq
- Medical Device CAPA (Corrective Action and Preventative Action): Tinyurl.com/ycqubsba
- ISO13485 V FDA CFR 21 Part 820: Tinyurl.com/y94bkf5w
- How To Obtain A European CE Mark: Tinyurl.com/yxzplrr2
- What is UKCA and UKRP: Tinyurl.com/cus6teyy
- What is an EC REP: https://tinyurl.com/59durub8

Boštjan Barbiš

Boštjan Barbiš

Head of Solution Delivery Europe | Rook Quality Systems

Boštjan Barbiš

Head of Solution Delivery Europe | Rook Quality Systems

Marcus

Marcus Carstensen

Co-Executive Director, CTO & Co-Founder | Optoceutics

Marcus Carstensen

Co-Executive Director, CTO & Co-Founder | Optoceutics

▸ Ph.D. from DTU Electrical Engineering (Photonics)

▸ Co-founder and CTO of OptoCeutics: A DTU and UC Berkeley spinoff

▸ Background in physics and engineering from DTU

▸ Published BSc. thesis in a peer-reviewed journal on high-speed holographic resonant later printing. The research project and technology later won the European Innovation Radar prize in Excellent Science, 2018

▸ Research assistant in experimental optics and electro-optics at DTU Nanotech and Fotonik during bachelor and graduate studies

▸ Awarded $3000 for best MSc. thesis and received around 1 million DKK in soft funding allocated to the research project

▸ Co-authored 10+ journal and conference papers

▸ Awarded a Visiting Scholarship at CITRIS, UC Berkeley, California

▸ Studied physics at Rensselaer Polytechnic Institute, USA, as part of my bachelor in 2015

▸ Teaching assistant at DTU for mathematics; volunteer at UNF for mathematics and data science camps

▸ Principal investigator for Optoceutics within the large Marie Skłodowska-Curie ITN EU Project, ASTROTECH, funded by Horizon 2020

▸ Co-supervisor to three Ph.D. students

▸ Secured over 7 million DKK in soft funding; raised over 30 million DKK in equity

▸ Lead on four patent families, co-writing three

▸ Five years of experience in regulatory and clinical affairs for medical device development under MDR 2017/745

Ralf Gansel

Ralf Gansel

Department Manager | TÜV SÜD

Ralf Gansel

Department Manager | TÜV SÜD

annette kristiansen

Anette Kristiansen

Senior Clinical & Scientific Affairs Director | Neurescue

Anette Kristiansen

Senior Clinical & Scientific Affairs Director | Neurescue

Experienced Senior Clinical & Scientific Affairs Director with responsibility for the Clinical, Regulatory and Scientific Affairs in Neurescue. ISO13485, ISO14971, ISO14155, GCP US, GCP Auditing & ICH/GCP Certificates.

I have a demonstrated history of working in regulatory and clinical affairs within the medical device industry. Currently in charge of regulatory, clinical, and scientific affairs within Medical Devices and startup companies. FDA submissions (510K and IDE) and MDD/MDR CE mark submission. With a proven record of 510(k) clearance and IDE approvals. Exception from informed consent (EFIC- CRF 50.24) submissions and planning community consultation and public disclosure for EFIC trials in the US. Preclinical investigations (GLP) in Denmark, the US, and France (6 finalized within 3 years resulting in 3 publications). Formative and summative usability studies in Denmark, US, and France. Clinical investigation submissions and approvals from to Ethical Committee and Competent authorities for class IIa, IIb, and III products in EU in emergency medicine according to the MDR.

In charge of developing data safety monitoring committees, clinical trial agreements (including trial budgets), and the development of SOPs and MOPs.

Previously performed clinical post-market studies in Germany, Denmark, and the US (Heidelberg, Copenhagen University Hospital Rigshospitalet, Harvard, Baltimore, Houston Medical Center, Stanford, and Yale).

Cofounder of Medtech Meetup which is a networking group for start-up companies. Mentor for MedTech start-up companies at DTU.

Edwin Lindsay

Edwin Lindsay

Principal Consultant/Managing Director | Compliance Solutions (Life Sciences)

Edwin Lindsay

Principal Consultant/Managing Director | Compliance Solutions (Life Sciences)

 Enrico Perfler

 Enrico Perfler

Founder | 1MED

 Enrico Perfler

Founder | 1MED

Enrico Perfler is a serial entrepreneur in the medical device industry, and he has accumulated over 20 years of professional experience in the field, particularly specializing in regulatory affairs of medical device technology.

In 2014, Enrico established 1MED SA, an innovative international company that provides a broad spectrum of services including regulatory support, digital solutions, and comprehensive Clinical Research Organization (CRO) services for the medical devices . The company caters to the medical device and in Vitro Diagnostic (IVD) products. Under his leadership, 1MED SA has been at the forefront of overseeing the development and regulatory approval of over 500 medical devices in Europe, thereby cementing Enrico's status as a pivotal figure in the MedTech sector. In 2020, 1MED, under Enrico’s direction as CEO, was recognized among the top 10 medical device life science outsourcing consulting/service companies in Europe.

Enrico's dedication to the industry is further highlighted by his role as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His contributions extend beyond academia to significant roles in standardization bodies, including his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, showcasing his commitment to advancing industry standards and ensuring the safety and efficacy of medical devices.

helene gustafsson

Helene Gustafsson

Director Clinical Value Proposition & Evidence | GE Healthcare

Helene Gustafsson

Director Clinical Value Proposition & Evidence | GE Healthcare

20+ yrs in the medical device and pharma industry with a core focus on leading motivated colleagues and developing valuable and safe products for healthcare professionals, patients and care givers.
Etienne-Nichols-headshot

Etienne Nichols

Medical Device Guru | Greenlight Guru

Etienne Nichols

Medical Device Guru | Greenlight Guru

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Páll Jóhannesson

Pall Johannesson

EVP Commercial Division | Greenlight Guru

Pall Johannesson

EVP Commercial Division | Greenlight Guru

M.Sc. in Medical Market Access, EVP Commercial Division at Greenlight Guru. Pall is also the founder of Greenlight Guru Clinical, the only EDC system specifically made for medical devices.

Helene Quie

Helene Quie

CEO & Founder | Qmed Consulting

Helene Quie

CEO & Founder | Qmed Consulting

Peter Sebelius

Peter Sebelius

Founder & CEO | Medical Device HQ

Peter Sebelius

Founder & CEO | Medical Device HQ

Medical device trainer | Standard author | Entrepreneur
 
Peter has been a member of TC210 since 2010 as well as JWG1 and JWG3 and has partaken in authoring the IEC 62366-1:2015, ISO 13485:2016 and ISO 14971:2019.
Morven S

Morven Shearlaw

Co-founder & Director | Fearsome

Morven Shearlaw

Co-founder & Director | Fearsome

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