Good Distribution Practice for Medical Devices (GDPMDS), Singapore
- Development and implementation of Quality Management Systems (QMS) in compliance with SS620:2016 (2021) – Good Distribution Practice for Medical Devices (GDPMDS) Requirements.
- Assisting medical device manufacturers, healthcare companies, and distributors in establishing commercial operations for the importation and sale of their products in Singapore.
Quality Management Systems (QMS)
- Development and implementation of Quality Management Systems (QMS) in compliance with international standards, including ISO 9001, ISO 13485, EU MDR/IVDR, 21 CFR 820, and MDSAP. Structuring Technical Documentation in accordance with international regulatory requirements.
- Coaching and training to prepare for ISO 13485 certification, including support with management reviews and supplier qualifications. Implementation and maintenance of Risk Management processes in compliance with ISO 14971.
- Facilitating data-driven continuous QMS improvements to enhance compliance and efficiency.
Training Program
- Quality Management Systems as per ISO 9001/ ISO 13485, EU MDR/ IVDR, 21 CFR 820, MDSAP etc.,
- Medical Device Single Audit Program (MDSAP)
- Risk Management according to ISO 14971
- EU regulations for medical devices (EU MDR/ EU IVDR)
- Conducting training programs on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Clinical Practices (GCP).