Join the AITC, BIO Alabama, ADOC, and BSI Group for a webinar on the UKCA Marking – with a focus on Biotech.
The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking, known as ‘new approach’ goods.
The UKCA marking came into effect on January 1 2021. However, to allow businesses time to adjust to the new requirements, you will still be able to use the CE marking until June 30 2023 in most cases.
- Export Alabama Alliance /AITC Introduction
- BSI Group
- What is the UKCA Marking and how do companies get approval
- Which countries/industries require the UKCA Marking
- With more focus on biotech/life science/medical device industries
- Similarities/Differences with CE Marking
- Update on UK Brexit
- Alabama STEP Grant program for the UKCA Marking
BSI, Regulatory Services, Medical Devices:
BSI is a trusted, world-class Notified Body and Conformity Assessment Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world. BSI UK is a UK Approved Body (UKAB). BSI’s mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and trusted worldwide.
BSI Medical Devices has a team of over 700. Within that team are our technical experts with experience encompassing the full range of medical devices and management system standards. Our services include system certification to ISO 13485, CE marking, product testing, and standardization to support your global market access goals.
BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. Both have full scope designations to the IVDR and MDR.
Our presenter will be Timothy Lee:
Timothy has been with BSI for over 6 years helping medical device companies understand and meet the global regulatory requirements for international markets. He has significant training under ISO 13845:2016, MDSAP, and the Directives/Regulations for EU CE Marking. He holds a Bachelors from the Univeristy of Washington and has worked for large manufacturers such as Kimberly-Clark, Coca-Cola, and Thermo Fisher.