Our Success Story

***New Success Stories For Consultancy Services to Singapore clients ***

  • Supporting and continue to support clients with implementation of ISO13485-2016 
  • Since 2018  provided consultancy for Software Verification and Validation (IEC62304) 
  • Since 2019  provided consultancy for Usability  Studies (IEC62366) 
  • Gap and recommendations for MDD to MDR & IVDD to IVDR.
  • Able to support regulatory approvals (via local partners) for major ASEAN countries and Taiwan.

Following our company’s philosophy, we are able to reach out to both SMEs and MNCs to successfully carry out the followings:

  • Application of Manufacturer, Importer, Distributor, Registrant License.
  • Application of Product License for Class A, B and C Medical Devices.
  • Performing Company Audits and Gap Analysis.
  • Conduct Training , Workshops on US FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
  • Advisor in developing programs and operating procedures to ensure compliance to regulatory requirements like US FDA 21 CFR Part 820, ISO 13485 and Singapore HSA’s GDPMDS (Good Distribution Practice for Medical Devices in Singapore).
  • Industry Training and Seminars in Risk Management and Quality Management Systems.
  • Quality Manuals and supporting documentation development.
  • Project Management.
  • Provide advisory services to clients on existing and new product development in relation to regulatory requirements and regulatory submissions in various countries including EU, USA, China, Singapore, etc.

We have also assisted recently SMEs who have recently started up in medical device import/distribution with regards to meeting the requirements from the local regulator in terms of licensing and product registration and also setting up QMS.

We are proud to announce that most of our clients are referrals from our existing clients.

In-house Training
This seminar was successfully conducted in 22 Mar 2011 at WCEGA Towers. The seminar focuses on Regulatory Affairs for Medical Device Development in Different Region. The key speaker for this event is Tan Hwee Ee, Founder and Principal Consultant of DH RegSys.

Expand Into China’s Medical Device Market
The seminar and workshop was successfully conducted on 30th and 31st August 2012 at Spring Auditorium. This event is jointly organized by Singapore Manufacturers’ Federation and DH RegSys and supported by SGS Systems and Services Certification. The seminar and workshop focuses on China SFDA Regulatory and Product Registration.

The key speaker for this event is Dr Song Xin Hua, Founder and General Manager, Shanghai Binyan Trade and Agent Co. Ltd. Assisting Dr Song with the seminar and workshop including translation is Tan Hwee Ee, Founder and Principal Consultant of DH RegSys.

Co-training Programme with SGS on CE Technical File
The workshop was successfully conducted  on 30th and 31st May 2013 at the Singapore Manufacturing Federation Building. This event is jointly organized by the Singapore Manufacturer’s Federation, SGS and DH RegSys. The workshop focuses on familiarizing delegates with the requirements of Directive 93/42/EEC as amended by Directive 2007/47/EEC and allowing manufacturers of medical devices to ensure continued compliance.

Key trainers for this event is Tan Hwee Ee, Founder and Principal Consultant of DH RegSys and Lee Lai Mei, Business Development Manager and Lead Auditor of SGS International Certification Services Singapore. 

OUR PARTNER
  • MD-CLINICALS Europe

    Route de Denges 28C
    1027 Lonay
    Switzerland

    Phone: +41 21 349 96 36
    Mobile: +65 98656730
    Fax: +41 21 349 96 37
    Site: www.md-clinicals.com
Call us at 6659 0979
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