Post Market Surveillance Plan Template - ISO 13485

ISO 13485:2016 QMS Template - Device Post Market Surveillance Plan (QMS.4.2.3.1.7)

Enhance your Quality Management System with our ISO 13485:2016 compliant Device Post Market Surveillance Plan template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

• Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 and Medical Device regulations.
• Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
• Compliance Assurance: Utilizing our template helps you maintain an effective post market surveillance plan, demonstrating robust quality management as required by ISO 13485:2016 and Medical Device Regulations.

What is a Device Post Market Surveillance Plan?

Medical device regulations require manufacturers to have a post market surveillance (PMS) plan as part of their compliance frameworks. This plan details the actions a manufacturer will take once their medical device has been placed onto the market, ensuring ongoing safety and effectiveness.

How Will the PMS Plan Template Help My Organisation?

The Device Post Market Surveillance Plan template helps your organization:

• Document Actions: Clearly outline the actions to be taken for monitoring devices after they have been placed on the market.
• Ensure Compliance: Meet the requirements of Medical Device Regulations and ISO 13485:2016 by maintaining a comprehensive PMS plan.
• Maintain Safety and Effectiveness: Continuously monitor and assess the performance of your medical devices to ensure they remain safe and effective.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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