Quality Management System
Medra+ has proven testimonies in preparation of various validation documents such as Design, Software, Machine, Manufacturing and Analytical protocol and reports. Medra+ has joined hands with various Certification bodies and acts as a mediator for client by providing all relevant documents required to submit for approval.
List of QMS standards supported by Medra+ are as follows:
| Standards | Description |
| SS620 | Singapore: QMS Transition from GDPMDS To SS620:2016 |
| GDPMD | Good Distribution Practice for Medical Devices |
| BizSafe | BizSafe Consultant (LEVEL 1 TO STAR) |
| GMP | Good Manufacturing Practice |
| PIC/S GMP | Good Manufacturing Practice for Medicinal Products |
| WHO GMP | Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) |
| GLP | Good Laboratory Practice |
| GDP | Good Distribution Practice |
| QMS alignment projects | Align current company’s QMS with latest standard requirements |
| ISO 13485 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 9001 | Quality management systems — Requirements |
| ISO 14001 | Environmental management systems — Requirements with guidance for use |
How can we help you?
Contact us for 1 hr free consultation
Contact us for 1-hour free consultation
Just submit your contact details and we’ll be in touch shortly.