CONSULTING SERVICE

OUR CONSULTING SERVICES

In EAP MedTech Consulting, we provide you the best consulting program that is lead by one of our consultant. We has been in medical industry for more than 20 years and we do assist businesses in the areas of marketing, product development, production, quality assurance, and regulatory affairs with a focus in Malaysia, Australia, Singapore, India, China, and Thailand bearing in mind EU and US relevant medical device regulations (e.g. EU MDD/MDR, US QSR)

MALAYSIAN LOCAL AUTHORISED REPRESENTATIVE FOR MEDICAL DEVICES

According to :

  • Malaysia Medical Device Act 2012 Act 737
  • Malaysia Medical Device Auhority Act 2012 Act 738
  • Medical Device Regulation 2012

QUALITY ASSURANCE AND REGULATORY AFFAIRS CONSULTING

  • ISO13485 Medical devices – Quality Management systems – Requirements for regulatory purposes
  • Good Distribution Practice Medical Devices GDPMD
  • ISO 14971 Medical devices – Application of risk management to medical devices
  • IEC 62366 Medical Devices -Application of Usability Engineering to Medical Devices
  • Technical File according to European Medical Device Directive (MDD) , Common Submission Dossier Template CSDT, US FDA 510k
  • Design development process
  • Process validation

PRODUCT DESIGN & DEVELOPMENT AND CONTRACT MANUFACTURING SERVICES

  • Medical device prototyping and design
  • Support product development and its relevant documentation in line with international regulatory requirements
  • Sourcing and Contract Manufacturing in line with ISO 13485/QSR of disposable medical devices and components, re-usable surgical instruments, active medial and in vitro diagnostic devices

Consulting Enquiries

Our specialists are at your disposal 24 hours round the clock to attend to your needs.
We also support you via telephone and email, no matter where you are in the world.

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