QUALITY MANAGEMENT SYSTEM COMPLIANCE
From design, manufacturing and distribution to post-marketing activities, a well-established Quality Management System (QMS) is key to all medical device stakeholders, especially in today's medical device industry.
QMS Setup - ISO 13485 & FDA QSR
For medical device companies, we work with you to develop a QMS through Stendard First, a cloud based software that help you generate documents to meet the widely accepted ISO 13485, as well as the US FDA Quality System Regulation (QSR). We have been through many rounds of certification audits to have understood what processes best suit your company. We will have you prepared for the official audit conducted by your appointed certification bodies.
SS 620:2016 (GDPMDS)
For companies interested to distribute your medical devices in Singapore, we can help you to develop to the new SS 620:2016, Good Distribution Practice for Medical Devices (GDPMDS), using Stendard First. This is a mandatory QMS to be implemented before your company can import and distribute medical devices.
Internal and Supplier audit
Internal audit must be actively performed to ensure compliance to regulations and standards. Apart from QMS (ISO 13485, US FDA QSR and SS 620) setup, we also perform internal audit training to your appointed internal auditors, as well as regular independent audits to rectify any non-compliance identified.
Supplier audit must also be performed, especially on your critical suppliers based on ISO 13485, US FDA QSR and SS 620 requirements. In this current generation where most companies outsource the design and/or manufacturing of their devices in parts or completely to contract manufacturers, a constant oversight is important. We will walk the ground with you during these audits to ensure that their activities are compliant to your specifications and regulatory requirements.