Quality Strategy

A Quality Strategy for Medical Device Company 

Quality Management 

A quality plan for Medical Devices

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and company from day one.

Regulatory requirements for medical device companies are stricter than ever before. We believe that quality planning can make or break innovative device manufacturers. Everyone needs to start with a “strategic plan which outlines the realization phase and defines the projects needed for quality throughout the product life cycle. No device manufacturer can afford to put off quality planning until “later". With a solid quality plan for medical devices in place, you'll empower your team with the framework to deliver a high-quality device.

A quality plan for medical device companies is a series of documents which defines the standards for a process, product, or organization, and provides detail on how these quality standards are achieved. ISO 13485 specifies that “each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.

A quality management system (QMS) for medical devices requires a plan, a manual, a policy, and SOPs. Understanding the structure of QMS documentation can illustrate why each of these types of quality documents plays an important role and how they all fit together.

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