Ultimate guide to placing a medical device on the EU market

Every medical device start-up dreams of market success and that first influx of revenue. But until you secure EU approval, the vast European market of half-a-billion people remains barred shut - and your company continues to spend money with nothing in return.

So how long does the typical process take, from design and development to product launch?

What are the key steps? And how can your business guarantee success? Join our webinar to find out.

Bullets/Learning Objectives

• Understand the end-to-end process for launching a medical device in the EU, and how long it will take

• Unpick the key steps to market, from classifying your device and building a QMS to passing your conformity assessments and audits

• Understand the right timing for creating your quality documents and applying for CE marking  

• Hear tips and best practice for a faster, more targeted route to market

Presenting Speakers & Company Information:

Sumatha Kondabolu

Tanja Rohark

Speaker Info:

Sumatha Kondabolu

Senior Quality Specialist, Qualio

Sumatha has 19 years of QA/RA experience across the medical device and pharmaceutical sectors. She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD and IVDR. She holds a Master’s in Chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, ISO 9001 and IATF 16949

Partner:

Tech Volution - The Gamechange

Tanja Rohark, CPO / CTO & Co-Founder

Tanja's heart has been beating for lean and effective quality management in medical technology, biotechnology, and the pharmaceutical industry for over 15 years.

Her passion is emerging technologies for Digital Transformation in healthcare, ranging from Digital Health Platforms to Health Apps/ Software as a Medical Device to gxp-compliant computer systems for business process automation.

With her IT consulting company Tech Volution she offers the "Fast Track" for medical technology start-ups and SMEs who want to embrace digital product innovations. This pre-configured regulatory roadmap promises a product launch within 12 months from ideation to the QMS and technical documentation to market launch and beyond, including building a digital integrated ecosystem with modern technologies, such as Qualio as an eDMS partner.

She holds an MSC in IT in Healthcare, along with certifications as IT Security Officer & Auditor for ISO 27001 (TÜV), Cyber Security ISACA/ BSI, Business Analyst & Requirements Engineer (IREB, UX, Human Centered Design) as well as IT Quality & Regulatory Compliance (for GxP CSV, ISO13485, IEC 62304 and more).

Email: tanja@techvolution.ch

LinkedIn: https://www.linkedin.com/in/tanjarohark