[ISO 13485 Cl 7.2] 

This clause requires the organization to determine and meet customer requirements related to the product and ensure effective communication throughout the product life cycle. It focuses on understanding customer needs clearly before committing to supply a medical device or service.

The intent of Clause 7.2 is to ensure that medical device manufacturers and suppliers:

• Understand what the customer truly requires (both stated and implied).

• Verify that they have the capability and resources to meet those requirements before agreeing to supply.

• Maintain effective communication with customers regarding product information, contracts, feedback, and complaints.

In the context of ISO 13485, the “customer” may include distributors, healthcare institutions, OEM partners, or end-users, depending on the organization’s role

7.2.1 – Determination of Requirements Related to the Product

The organization must identify:

• Customer-specified requirements, such as product specifications, performance, labeling, or packaging.

• Regulatory requirements, such as CE marking, FDA 510(k), or labeling laws applicable to the destination market.

• Unstated or implied requirements essential for the intended use (e.g., patient safety, biocompatibility).

• Additional company-specific requirements, such as internal quality or delivery standards.

Example: If a customer orders a sterile catheter, the manufacturer must ensure not just sterility but compliance with regulatory sterilization standards and labeling requirements.

7.2.2 – Review of Requirements Related to the Product

Before committing to supply, the organization must:

• Review and confirm that all customer and regulatory requirements are clearly defined and documented.

• Verify that it has the capability, capacity, and resources to meet those requirements.

• Resolve any differences between the order, contract, or tender and the proposal before acceptance.

• Maintain records of review and approval.

Example: The sales or QA team should review the customer’s purchase order, ensuring product codes, labeling language, and sterilization methods match approved specifications before confirming the order.

7.2.3 – Communication

The organization must establish effective communication channels with customers covering:

• Product information (features, specifications, instructions for use).

• Contract handling, including order acceptance, amendments, and changes.

• Customer feedback and complaints, including field safety corrective actions (FSCA) and vigilance reporting.

Example: A designated customer service or regulatory team handles incoming complaints, product return requests, or notifications of adverse events, documenting each case as per QMS procedures.