Services Offered
We offer the full spectrum of services to help organizations work better. Everything from creating standards of excellence to training your people to work in more effective ways, assessing how you’re doing, and helping you perform even better in future. Very few others do this, and none have been doing it as long as we have. We can combine any of our products and services to create a package that’s tailored to your business. This removes the complexity and unnecessary cost of getting you where you want to be – whatever your starting point.
Authorized Representative
- Act as your primary regulatory contact with the Malaysia Medical Device Authority, from registration to post-market activities.
- Submit all necessary medical device registration documents to the CAB and MDA and assist with any follow-up questions.
- Assist in evaluation and selection of distributors that are allowed to import medical device.
- Assist in adverse event reporting to MDA and device recalls.
Product Registration
Our in-house experts will compile your technical documents and prepare customized dossiers such as the CSDT for medical device registration in Malaysia. We are experienced in liaising with the Conformity Assessment Body (CAB) for Full Conformity Assessment and/or Verification. We also have a proven track record of completing dossiers efficiently with minimal questions and feedback received from MDA.
Establishment License
We have a team of consultants who are well-versed in the requirements and the MedCast System to assist you with your applications. The step-by-step guidance and consistent follow-up will help to expedite the application and approval process.
Training
We offer a wide range of training programs that are designed to improve the competency of your staff by enabling them to learn and practice in the most efficient and effective manner. All our trainings are customized based on your needs to meet your requirements.
- ISO Standard Interpretation/Awareness Training
- ISO Standard Internal Auditor Training
- Legal Requirements Training
Our Consultation Services Category
Learn more about our consultation service types by click the buttons below: