BEGIN:VCALENDAR
PRODID:-//Columba Systems Ltd//NONSGML CPNG/SpringViewer/ICal Output/3.3-
 M3//EN
VERSION:2.0
CALSCALE:GREGORIAN
METHOD:PUBLISH
BEGIN:VEVENT
DTSTAMP:20210621T073157Z
DTSTART:20210701T140000Z
DTEND:20210701T144000Z
SUMMARY:Digital Health Technologies Regulatory Event
UID:{http://www.columbasystems.com/customers/uom/gpp/eventid/}h64-kpmevon
 0-vaipx6
DESCRIPTION:This event is part of the Demystifying regulations and commer
 cialisation mini-series\, hosted through the Christabel Pankhurst Instit
 ute for Health Technology Research and Innovation. These events\, taking
  place in June and July 2021\, are organised by Advanced Materials in Me
 dicine (AMM)\, Translation Manchester\, Digital Futures\, the University
  of Manchester Innovation Factory\, and the Institute of Data Science an
 d AI.\n\nAlso tieing into the Manchester Connected Health Ecosystem\, th
 e event is aimed at world leading academic expertise\, industry partners
  from SMEs to major international digital & pharma companies\, Health an
 d Social Care professionals across the NHS\, Public Health and local gov
 ernment\, and patient and service user representatives.\n\nUnderstanding
  Medical Device Regulations & Design Control\n\nWe are proud to announce
  Richard from QMS Consultancy Ltd is hosting a Medical Device Regulatory
  Clinic\, as part of the wider Demystifying Regulations & Health Economi
 cs Mini-Series. Richard will be sharing his experience by defining what 
 it takes to gain Regulatory Compliance for MD’s\, IVD’s and Stand-Alone 
 MD Software (SaMD).\n\nQuestions answered during the Regulatory Clinic i
 nclude:\n\n- Is my innovation a Medical Device?\n\n- How do I classify a
  MD\, IVD\, SaMD\, Digital Technology\, Telemedicine etc?\n\n- What is a
  typical roadmap to Regulatory Compliance?\n\n- What is ISO 13485 (softw
 are) and how do I get certified?\n\n- What is meant by Design Control an
 d how does this relate to TRL’s (Technology Readiness Levels)?\n\nFollow
 ing a 45 minute presentation Richard will throw questions out to the flo
 or. Those wishing to know more and to gain a 1-2-1 assessment of their s
 pecific device or technology can book an appointment on Richards calenda
 r from this link.\n\nRelevant funding opportunity: Access to Expertise a
 ward (Translation Manchester)\n\nThe timely Access to Expertise award fr
 om Translation Manchester enables researchers to access appropriate expe
 rtise to help unblock specific bottlenecks associated with translational
  research. Researchers can apply for up to £25\,000 to access technical 
 expertise such as (but not limited to): bioinformatics\, biostatistics\,
  physicians and nurses time\, software\, app design or programming exper
 tise and regulatory advice. Call will open in the summer with projects e
 xpected to start in November. Information on previous calls are availabl
 e on this page of the Translation Manchester website.
STATUS:TENTATIVE
TRANSP:TRANSPARENT
CLASS:PUBLIC
END:VEVENT
END:VCALENDAR