Singapore Manufacturing Federation (SMF)’s two organisations – Centre of Corporate Learning (CCL) and Standards Development Organisation (SDO) jointly organises a series of competence devleopment workshops for the medical technology and healthcare industry in Singapore
Introduction to Critical Standards for Medical Device Development & Commercialisation
Safety and Efficacy are the two most important things needed for any medical or healthcare product. Safety and Efficacy is usually being guided by various international and local standards to ensure this.
With the SDO’s initiative to promote standards awareness and standards adoption in the medical technology and healthcare industry, a “Standards Appreciation Workshop” series was designed to provide an overview of the various standards used by the industry, when to use it and the status of worldwide adoption today.
The realization of a new medical device can be very costly and time consuming. Failure to meet the required level of quality, safety and reliability often lead to substantial set back to the organization, and sometimes its very survival. At this workshop, participants will find out about the essential international standards that are critical for the development and commercialization of medical devices. While some of these standards are regulatory requirements, this workshop will also highlight some important voluntary international standards that potential product owners should consider adopting during product development.
The workshop also aims to provide this introduction to aspring teams and organisations to have a headstart when venturing into the world of medical technology and healthcare.
Update 13 April:
The first session, well became TWO sessions because it was sold out and we had to do a second workshop on the same day, which also sold out!
We had a collection of medical device comapniese, academia, startups, consultants, distributors, tech transfer offices, even from a CRO, learning about the standards at the top level, to gain that initial appreciation.
Introduction to Critical Standards for Medical Device Development & Commercialisation – Check back on this button for the new date in July 2017!
ISO13485: Clause by Clause and Being Audit Ready
CCL’s mission is to provide training and devleopment to the SMF member companies and beyond, to deliver value to all levels of the hierarchy, which translate to greater competitiveness for the organisations.
The ISO 13485 is widely adopted in many countries as a regulatory requirement for the product realisation of medical devices. This International Standard provides the quality management system framework to ensure the consistency in design, product development, manufacturing processes, supplier controls, installation of equipment and delivery requirements to direct customers or distributors. As the transition to this version of the standard draws near, it is ideal for the Professionals in Quality, Regulatory, Executive Management, Manufacturing/ Operations, R&D, Product Development, Supply Chain of medical technology companies still planning their transition, medical technology startups, spin-offs, companies aspiring to be in the medical technology industry, and technology transfer offices
This series of workshops perfectly aligns with CCL’s objectives in upskilling the workforce in a cost-effective manner, delivering maximum value. It also aligns with SDO’s standards adoption initiatives. Finally, it aligns with Access-2-Healthcare’s vision to enable education in a way to ultimately improve the way medical technology reaches the market and how healthcare is delivered.
There are currently 3 months in which this workshop is being organised by SDO and CCL – May, July and September*
Update: April Dates moved to May
|Clauses – 24 May
|Audit Ready – 25 May
|Special 2-Day Package – May
|Clauses – 20 July
|Audit Ready – 21 July
|Special 2-Day Package – July
|Clauses – 21 September
|Audit Ready – 22 September
|Special 2-Day Package – Sept
Dates may be changed by SDO and CCL’s discretion, do check frequently for updates