QMS for Medical devices

ISO 13485 is the medical device industry’s most widely used International Standard for quality management. ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), and the EU Medical Device Regulation (MDR).

ISO 13485 is one of the many services offered by TopCertifier, the global consulting and certification solutions provider. Myanmar is a potentially emerging medical sector. ISO 13485 could be used by businesses in the medical device industry to improve standards and increase efficiency. We deliver ISO 13485 consulting and certification services to all major locations in Myanmar including Yangon, Mandalay, Bago, Pathein

By getting ISO 13485 certified, there is an opportunity for increased business opportunities in both existing and emerging markets. There is also a general improvement in the quality of the service/product provided to the consumer. This certification will give you a distinct edge over your rivals and will help in acquiring new clients.

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GET CERTIFIED IN 5 STEPS




1. CALL/EMAIL US AND SHARE YOUR REQUIREMENTS

We will do a FREE GAP analysis of your organization with respect to ISO 13485 Standard and give you a quote.

2. TRAINING AND DOCUMENTATION

Once you have agreed to our quotation, Our team will provide the required trainings to you and will complete the documentation work required for ISO 13485 certification.

3. IMPLEMENTATION AND REVIEW

We will then conduct a pre assessment audit to ensure that you organization meets the desired certification requirements.

4. FINAL AUDIT BY CERTIFICATION BODY

We will provide assistance during final certification audit to ensure that your organization achieves certification successfully.

5. RECEIVE CERTIFICATE

We are a quality conscious organization and believe in Total Customer Satisfaction. So if you are 100% satisfied and happy with our service, make payment to us.

Get our free consultation today!

Our hassle free certification process has been designed to assist your company to achieve certification in just 7 – 30 days of time.

our experts

EXCELLENT ADVISORS

Mr. Vinay Kumar - Myanmar

MG Vinay Kumar
Founder & CEO
Myanmar

MG Vinay Kumar

Founder & CEO

Mr. Vijay Boregowda - Myanmar

Vijay Boregowda
Founder & CEO
Myanmar

Vijay Boregowda

Founder & CEO

Mr. Subhash Mashalkar - Myanmar

Subhash
Administrator
Myanmar

Subhash

Administrator

Mr. Syed Usman - Myanmar

SYED USMAN
Sr. Consultant
Myanmar

SYED USMAN

SENIOR CONSULTANT

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CLIENT SAYS

It streamlined a lot of processes. Very pleased. We thought it would be a horrendous amount of work, but were greatly surprised and pleased instead.

Mr. Mike Powell - Director, LabMate
Cape Town, South Africa

The process improvement training was fantastic. Since our focus was more on process improvement than certification it really helped the team.

Mr. Ayman Barquawi - Director, Red Sea Gateway
Jeddah, Saudi Arabia

Did exactly what was required without going overboard. A manageable system. Worked with existing systems. It was easy to step up and improve.

Mr. Rowan Daniel Davis - Director, Food Service Trading Co WLL, Baharian
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