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Ultimate guide to placing a medical device on the UK market

Andrew joined Qualio, the leading eQMS supplier, to talk about placing a medical device on the UK market.

Every medical device start-up dreams of market success and that first influx of revenue. But until you meet UK MDR requirements and register with the MHRA, the lucrative UK market 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? Watch the webinar recording to find out.

Bullets/Learning Objectives

• Understand the end-to-end process for launching a medical device in the UK, and how long it will take
• Unpick the key steps to market, from classifying your device and building a QMS to passing your MHRA inspections and securing UKCA marking
• Hear tips and best practice for a faster, more targeted route to market

Presenting Speakers: Kelly Stanton; Andrew Whitton

View the article on Qualio

Medical devices in Europe: busting myths and misconceptions

Andrew joined Qualio, the leading eQMS supplier, to talk about medical devices in Europe: busting myths and misconceptions.

Cracking the European market for your medical device or in vitro diagnostic device can be a long and complex process.

And companies tackling EU legislation for the first time - such as start-ups or non-European organizations - can be led astray by common myths and misconceptions.

What do Class I devices actually require? How do EU requirements compare to non-EU territories, such as Switzerland? What does good post-market surveillance really look like?

We’re tackling confusion, myth and FAQs to give you a clear and sensible pathway that gets your device through the doors and into Europe.

Bullets/Learning Objectives

• Understand the real European regulatory requirements for your medical device or in vitro diagnostic device
• Dodge common myths and mistakes for a confident, right-first-time journey to market
• Master your quality and compliance obligations and learn how to adopt the right tools and process for long-term market success

View the article on Qualio

Unlocking the British and European markets with UKCA and CE marking

Andrew joined Qualio, the leading eQMS supplier, to talk about 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

Presenting Speakers: Lola Furlong; Sumatha Kondabolu; Andrew Whitton

View the article on Qualio