Speaker: Somashekara Koushik Ayalasomayajula, Senior Consultant

Date: November 7th 2023, Online

Duration: 4 hours | 2:00 – 6:00 PM CET, 8:00 – 12:00 AM EDT

About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer with 4+ years of experience within the medical device industry in product development and quality & regulatory affairs. Koushik supports our courses related to quality and regulatory affairs, deploying QMS according to ISO 13485, integrating MDSAP, GMP requirements and in the preparation of technical documentation of medical devices for global regulatory submissions. Koushik is ASQ certified Medical Device Auditor (ASQ-CMDA) and holder of RAC Devices from RAPS.

Training Objectives:

  • Understand the regulatory landscape of medical devices in the UK 
  • Understand UKCA marking and how to demonstrate compliance 
  • Understand how to align conformity assessment procedures to meet UKCA and CE marking requirements

Training Content:

UK regulatory landscape for medical devices:

  • UK Medical Device Regulations explained 
  • Obligations of Economic Operators 
  • Medical device guidances and use of standards in the UK

UK Conformity Assessment: 

  • Placing and making available on the UK market
  • Role of manufacturer 
  • UK Responsible Person 
  • UK Approved bodies and Conformity assessment routes

Technical files and UK Declaration of Conformity: 

  • Differences and similarities between UK and EU technical files 
  • Aligning UK and EU conformity assessment procedure 

UKNI marking and future medical device regulation: 

  • Sale of medical devices in Northern Ireland 
  • Proposed future changes to UK regulations 

Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive a training certificate)

Who Should Attend:

Quality, regulatory, and technical professionals working in the medical device industry. 


EUR 415 incl. course material and certificate

More Info & Registration: