Template: SOP Sales

Regulatory Requirement	Document Section
Medical Device Regulation Article 7	All
ISO 13485:2016 7.2	All

Summary

This SOP outlines the procedures for offering and selling the organization’s medical devices, including involvement in trials and research projects. It ensures that only approved devices and services, compliant with regulatory standards, are marketed and sold.

Process Owner	\
Key Performance Indicators	\

1. General Considerations

1.1 Marketing Material

The Sales team is responsible for preparing marketing materials based on the device’s technical documentation. This material includes all statements related to the functionality, usability, and performance of the medical device and must be approved by both the PRRC and QMO prior to use. The Sales team is also tasked with maintaining up-to-date marketing content.

1.2 Company Product Portfolio

The organization’s product portfolio, within the sales and marketing context, comprises all products and services that have completed development, certification, and registration processes and are cleared for sale.

1.3 Special Requirements for Client-Facing Roles

In compliance with German regulations, individuals in client-facing roles must receive training as Medical Device Consultants.

Optional additions:

• Guidelines for using a CRM tool.
• Instructions on storing and managing customer-related information (e.g., using a dedicated Google Drive folder for each customer).

2. Process Overview

2.1 Compilation of Marketing Material for Medical Device

The Sales team creates marketing materials based on the technical documentation and ensures they remain current. Both PRRC and QMO must approve these materials to confirm:

• Compliance with regulatory requirements in the region of use.
• Consistency with technical documentation, including intended use, risk management, clinical evaluation, and user manuals.

If the technical documentation is updated as part of change management, marketing materials must be re-evaluated.

Participants	Sales team
Input	New released medical device
Output	Released marketing material

2.2 Marketing of Medical Device

Before a marketing event (e.g., client presentation, conference, or external event), any product-related claims must be reviewed for compliance against the approved marketing material. The responsible employee must seek written approval from either the Sales team leader or the QMO. This approval should be documented and retained.

Participants	Any employee
Input	Draft of specific marketing material (e.g., presentation, flyers, posters)
Output	Approved specific marketing material, Documented approval

Optional additions:

• Detailed process for lead management: generating, qualifying, and contracting B2B leads.
• Protocols for storing and sharing customer data, including informal interactions like phone calls.
• Minimum documentation requirements and potential NDAs.

2.3 Compilation of Customer Contract/Offer

Note: applicable for B2B customers and should be tailored to the company’s operations.

Portfolio-based requests:

The Sales team assesses whether the organization has the capacity to fulfill the customer’s project needs, such as service capabilities, product delivery, and maintenance. Management approval may be needed. If the evaluation is positive, an offer or contract is prepared; if not, the project is terminated without extending an offer.

All offers/contracts must be submitted in writing (e.g., via email) and documented in \. Key differences between customer requests and the offer/contract should be clearly outlined.

Non-portfolio, new device requests:

If the request involves a new medical device or feature not in the existing portfolio, the Sales team consults Management to determine if development efforts should be pursued. If development is not approved, the project is terminated without an offer.

If approved, the Sales team seeks guidance from the development team and QMO on gathering customer requirements. A customized offer/contract is then prepared, requiring Management and QMO approval, which should be documented. This offer/contract is submitted in writing and recorded in \, highlighting any differences from the customer request.

Participants	Sales team
Input	Customer request
Output	Submitted and documented standard or custom offer

2.4 Finalizing Customer Contract and Key Account Management

Once the customer signs the contract, a copy is stored in \. A point-of-contact is designated within the Sales team and communicated to the customer, initiating the deployment process.

Participants	Sales team
Input	Submitted standard or custom offer/contract
Output	Deployment process initiated

2.5 Handling Feedback

The Sales team proactively seeks customer feedback and follows the organization’s feedback management process.

Immediate vigilance is required for any complaint indicating:

• A potential or actual incident that led to death or serious health deterioration.
• A significant issue impacting device performance, as detailed in intended use, the user manual, or marketing material.

Serious health deterioration includes:

• Life-threatening illness or injury.
• Permanent impairment of body structure or function.
• Hospitalization or extended stay, or conditions requiring medical or surgical intervention.
• Chronic disease.
• Indirect harm from incorrect diagnoses when used according to the manufacturer’s instructions.

Participants	Sales team
Input	Ongoing customer project
Output	Initiated feedback management or vigilance process

---