Medtech specific modules

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(February 1, 2017 | 10-11am | by Kyun Thibaut, Covartim)bw-kyun-covartim

  •  What is a medical device? Definition as per Directive 93/42, difference with a drug and examples of devices
  • Current trends in the Belgian medtech industry (regenerative medicine, ehealth, minimal invasiveness…)

(February 1, 2017 | 11.15am-1.15pm | by Peter Schrauwen, Rescop & Kyun Thibaut, Covartim) peter-schrauwen-rescopkyun-covartim

  • Nature of the medical device & specifics (competent authorities, regulations…): In Vitro Diagnostics, Software, Medical Device and Advanced Therapy Medicinal Products
  • Classification method for risk level assessment of MD as per EU directive
  • Labelling and Instructions for Use

(March 9, 2017 | 9-11am | by Ruth Beckers, Qualix & Kyun Thibaut, Covartim) kyun-covartimruth-beckers

 

  • Overview of the EU regulatory framework and impact of recent changes post PIP implant issue
  • ISO 13485: importance and certification process. How different is it from the product CE marking?
  • Introduction to the US regulatory framework and main differences with the EU system

(March 9, 2017 | 11.15am-1.15pm | by Peter Schrauwen, Rescop & Kyun Thibaut, Covartim) bw-kyun-covartimpeter-schrauwen-rescop

  • CE marking definition and importance
  • Certification routes (as per EU directive annexes) & processes
  • Major change management with the notified body after CE marking
  • Post-market surveillance & recalls : what needs to be done for materiovigilance and how to communicate it

(April 26, 2017 | 9-11am | by Kyun Thibaut, Covartim) kyun-covartim

  • Traceability throughout the development cycle : Design control according to ISO 13 485 and implementation
  • Production management
  • Unique Device Identifier (regulation in the US + EU)

(April 26, 2017 | 11.15am-1.15pm | by Kyun Thibaut, Covartim) kyun-covartim

  • Introduction to biocompatible materials, impact on their origin (animal, human…)
  • Introduction to prototyping methods (stereolithography, functional mock ups…)
  • Introduction to production techniques (3D printing, machining, thermoforming, moulding…)

(May 4, 2017 | 9-11am | by Stéphan Ploquin, MD101 & Kyun Thibaut, Covartim)

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  • Introduction to biocompatibility, packaging, shelf life & sterilization validation
  • Introduction to pre-clinical validation methods (e.g. simulated use, bench testing, in silico, in vitro, in vivo animals…)

(May 4, 2017 | 11.15am-1.15pm | by Anne-Laure Bailly, MD101 & Kyun Thibaut, Covartim) kyun-covartimbw-anne-laure-bailly-md101

  • Clinical trials regulation and differences between pre-clinical, pre-market and post-market clinical trials
  • Set up of a clinical trial and related documentation
  • Reporting and follow up

(June 8, 2017 | 9-11am | by Ernesto Noguiera, MD101 & Kyun Thibaut, Covartim) bw-ernesto-noguiera-health-economicskyun-covartim

  • Definitions and terminology of health economics: Cost vs benefit ratio
  • Cost utility matrix
  • Health technology assessment

bw-jean-creplet(June 16, 2017 | 9-11am | by Jean Creplet, Blue Belly Button & Kyun Thibaut, Covartim)kyun-covartim

  • Introduction to regulations in Belgium and differences with other countries (a.o. US)
  • Introduction to the nomenclature
  • Description of the global process for reimbursement in function of medical device types.