Unlocking the British and European markets with UKCA and CE marking

Without a CE mark, or its post-Brexit equivalent the UKCA mark, the pathway between your medical device and millions of potential European and British patients is barred shut.

CE and UKCA marking certifies that your medical device is safe, effective and compliant - and completing the certification process is unavoidable if your medical device business is to expand into these areas.

Our webinar will guide you through everything your business needs to know about CE and UKCA marking, from process requirements and product compliance tips to audit preparation and common mistakes.

Bullets/Learning Objectives

• What CE and UKCA marking means for your medical device business
• Beginning-to-end guidance of the certification process
• Compliance tips, tactics and recommendations
• How to make sure your CE and UKCA auditors leave happy

Speaker Info:

Lola Furlong

Senior Quality Specialist, Qualio

​​Lola is an ASQ Certified Medical Device Auditor who has extensive experience working in the medical device industry for large multinational corporations and start-ups in Europe and North America. As a Senior Quality Specialist with Qualio, she works closely with customers to implement and maintain their eQMS, helping them to achieve their quality goals and bring their product to the market efficiently.

Sumatha Kondabolu

Senior Quality Specialist, Qualio

Sumatha Kondabolu has more than 18 years of quality and regulatory experience in the medical device and pharmaceutical industries. She has spent time with start-up, mid-size and multinational companies. Kondabolu has experience in implementing quality management systems—requirements for regulatory purposes US FDA QSR, Canada’s Medical Devices Regulations, NIOSH, and specific requirements of the medical device regulatory authorities participating in the MDSAP program, COFEPRIS, and EU MDR, EU IVDD/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, IATF 16949.

Partner:

Andrew Whitton
Managing Director, Insight Regulatory

Andrew has an engineering doctorate in medical devices and is a talented and versatile consultant who has accumulated over 15 years’ experience in medical device and IVD design and development, regulatory affairs and quality systems, while holding a number of senior positions within a range of companies.