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Malaysia Medical Device Consultant

AYS Associate Consultant is a professional consulting firm that offer the service of consultation on improving and enhancing the quality systems, project development and business services of a company. We provide an extensive range of consultation services based on national and international standards.

Established since 2013 with Registration No SA0422122-U, we are committed to offer the best service to all our customers. Our aim is to provide total coaching, mentoring and solution for quality system Implementation and training services.

Since we open for business (2013), We had successfully assist more than 100 SME's to complete their QMS Standard, regulatory and act compliance in Malaysia. 


Our Hospitality Consultant successfully to open more than 30 Hotels & Resorts with our AYS Hospitality Group 


AYS Associates Consultant to be the top, in providing solutions to our customers and valued for the ability in giving the best advice possible.


To help our customers to enhance their system quality, project management and assist them in developing their business further.


To complete our task and project management within the time frame in professional responsibility 

To ensure all procedure, regulatory and compliance to be follow in governing laws

To find solution and given idea for SME;s in handling issues during our services/consultation 


To Ensure our client meat their target, goal and demand when deal with us..


Medical Device Regulatory

Act 737 (1) & (2) (Malaysia)


  • ISO 13485

  • Medical Device Registration.

  • Product Registration MDA

  • License Establishment

  • MDA Registration (All)

Quality Management Systems

  • ISO 9001-2016

  • ISO 13485

  • ISO 22000

  • ISO 14001

  • OHSAS 18001

  • MSPO

M'sia Standard Requirement

  • GMP



  • Mesti

  • Bess

SME Business Start Up 

  • Product Development

  • OEM Product design

  • OEM Coaching

  • OEM Mentoring

  • OEM Lab Test

  • OEM Manufacturing

Retail Business Consultant

  • FRANCHISE Program

  • LICENSE Program

  • NEW Opening Premise

  • Branch & outlet Set Up

  • Training & Consultation

  • FMCG Product Development


 International Branding Design

  • Starwood

  • Marriot

  • Accor

  • Langham

  • Movenpick Hotel & Resort

  • Shangri La

 Design & Build Hotel & Resort

  • Star Hotel (3,4,5)

  • Budget Hotel

  • Boutique Hotel.

  • Resort & Wellness Spa 

  • Convention center

  • Service Apartment

  • Hospitality spa

 Consultation & Management

  • New Opening Hotel & Resort

  • Taking Over Management

  • Operation Design

  • SOP Design & Training

  • Re branding (new brand)

  • Submission & approval (Licence) 

 Islamic Quality Standard Hotel

  • IQS : MS 2018

  • Awareness

  • Training

  • Audit

 Investment in Hotel & Resort

  • Land in prime location

  • New Hotel & Resort

  • Project Venture

  • Project Investment 

  • Funding 

  • Project Partnership