Ensuring Regulatory Compliance In Medical Manufacturing

Published 2024-07-26 · Wisdom Industrial Group

Global Standards

Medical devices must comply with various international standards and regulations, including ISO 13485, FDA regulations and CE marking requirements. Each of these asks questions about the factory, not only about the device, which is why the choice of manufacturing partner is a regulatory decision rather than a purchasing one.

Regulatory Compliance Support

Quality Management Systems

Implementing robust quality management systems is essential for making sure all products meet the necessary regulatory requirements. At Sanpin Medical the quality system is overseen by our French partner's management, which is what keeps compliance with European and American standards consistent rather than dependent on who is on shift.

Medical Device Manufacturing

Documentation And Reporting

Maintaining detailed documentation and accurate reporting is crucial for demonstrating compliance and securing regulatory approvals. Documentation is generated as production runs or it is reconstructed later, and only one of those survives an audit.

Medical Device Moulding

Where The Environment Comes In

Environmental control is one of the areas an auditor will examine, because it is one of the few that cannot be retrofitted. Clean room facilities are designed to comply with regulatory requirements, and moulding inside them is what makes the compliance claim true rather than aspirational.

Clean Room Injection Moulding

Certification Support

Our French partner assists clients in obtaining FDA and CE certifications. For companies entering European or American markets for the first time, that assistance is usually the difference between a submission that moves and one that circles.

Medical Compliance Pathway

Medical Devices capabilities