ISO 13485 : 2016

mda registration

Let the professionals handle the professional work

experienced consultant

Good quality is cheap, bad quality is expensive

advising on plant layout

Let's do it RIGHT from the beginning

No hidden charge

Fee is charged based on "per project", not "per manday"

choose your package

Fee is charged based on No of Production Line

RM 40,000

Package A

  • 1 Production Line
  • 3 - 6 Months Consultation
  • Guidance from A- Z
  • Reliable consultant
  • Hassle-free
RM 46,000

PACKAGE B

  • 2 Production Lines
  • 3 - 6 Months Consultation
  • Guidance from A - Z
  • Reliable consultant
  • Hassle free


RM 6,000

ala carte

  • For every additional of 1 Production Line
  • Applicable for those who purchase package A or B
  • Guidance from A -Z
  • Reliable consultant
  • Hassle free

Frequently asked questions

ISO 13485 is an efficient Quality Management System in medical device manufacutring to help you ensure your product quality.

Stage 1:  Awareness training, establishing and reviewing the documentation (1.5 months)

  • ISO 13485 awareness training 
  • Setting up ISO 13485 QMS based on the requirements (as per standard)
  • Review on the existing manual, procedure and forms
  • Revise and upgrade the existing documents

Stage 2: Guidance on implementation of requirements, internal audit and management review (2 months) 

  • Guiding staff during implementation of new standard
  • Monitoring KPI and achievement
  • Consultant acting as the lead auditor and guiding the appointed-auditor (by company)
  • Performing internal audit and updating the audit report
  • Follow up on the internal audit findings
  • Guidance on conducting management review meeting
  • Updating management review minute and reports

Stage 3: Follow up on Certification audit findings (1 week)

  • Follow up on the internal audit findings
  • Closing the non conformance if any

Estimated 3 – 6 months for new application. 

Only 2 type of fees are involved.

  1. Consultation fee
  2. Audit fee (audit fee is paid to a 3rd party company, which you can choose your own auditor or recommended by us). 

Pls refer to the price box above. 

You may estimate

1st year: RM20k

2nd & 3rd year: RM8k          

However pls check with the respective audit firm as the audit firm is a 3rd party company, not us. 
So the price stated here is just for reference. 

If the company is following our guidance, then the success rate will be 100%. 

  • Comply to law
  • Produce quality medical product 
  • Provide trust and confidence to stakeholders 
  • Tender / project 

 

Our consultant has more than 15 years of experience in related industry.

  1. Clear workflow
  2. No hidden charge
  3. Fee is charged per project, not per man-day. 
  4. Experienced and reliable consultant. 
  5. Guidance from A – Z. 
  6. MDA registration 
  7. License Establishment 

Petronas, Mydin, Koong Woh Tong and many others.

Upon confirmation and pay 10 days before the commencement: 

  • Stage 1: 50% of total cost
  • Stage 2: 25% of total cost 
  • Stage 3: 25% of total cost 

PS: Travelling allowance will be bare by client for out-of-Klang Valley consultation project.

Please fill up your ISO 13485 Engagement form here

Get ISO 37001 Consultation done in estimated 3 – 6 months. Kindly fill up your company details HERE to kick start the project!