GP-009 Sales

Purpose

This general procedure describes our sales process. It includes a list of the customer segments, the procedure to follow when a customer requests a quotation, the methodology to prepare a budget, the review process, and the implementation phase.

Scope

This procedure applies to all our sales activities, especially those related to the medical devices that we manufacture.

Responsibilities

JD-001 General Manager

Supervises the sales process and ultimately signs contracts with customers. The JD-001 is also responsible for the overall strategy of the company, which includes sales.

JD-002 Sales Manager

Leads our sales efforts and coordinates the business development team. They often lead the contracting process. They also design and implement the business development strategy, including pricing, sales targets and so on.

JD-003 Design and Development Manager

Leads the product development efforts, and guarantees the compliance of the sales process with the regulatory requirements applicable to medical devices. They also ensure that the product requirements issued by the clients are transferred to the design and development of the products.

JD-004 Quality Manager & PRRC

Ensures that all products and processes meet regulatory standards and quality requirements, particularly those related to medical devices. This role involves overseeing quality control, compliance audits, and maintaining certification standards.

JD-005 Technical Manager & PRRC

Manages the technical aspects of product development and ensures that all technical requirements are compliant with regulatory frameworks. This role is critical for maintaining the technical integrity and safety of medical devices.

JD-007 Technology Manager

Leads the company technology strategy, overseeing the development, implementation, and management of technological solutions. They ensure that technology systems support both operational efficiency and product innovation.

JD-008 Sales Development Representative

Focuses on identifying and qualifying leads for the sales team. This role involves outreach, prospecting, and initiating the early stages of the sales process to build the sales pipeline.

JD-011 Communications Manager

Manages both internal and external communication strategies, including brand messaging, public relations, and content creation. This role is key in maintaining a consistent corporate image and effective communication with stakeholders.

JD-012 Executive Assistant

Provides high-level administrative support to the executive team, managing schedules, organizing meetings, and handling communications. This role is essential for streamlining executive operations.

JD-013 Project Manager

Is responsible for planning, executing, and overseeing projects to ensure they are completed on time, within scope, and on budget. They coordinate between different departments and manage resources to ensure successful project delivery.

JD-016 Customer Success Manager

Ensures that customers are fully supported throughout their journey, focusing on product adoption, satisfaction, and retention. They work closely with clients to help them achieve their goals using the company's products or services.

JD-019 Business Development

This role is focused on identifying growth opportunities, building partnerships, and expanding the company's reach into new markets. This role is critical for driving long-term revenue growth.

Summary of roles and responsibilities

Job	Primary Focus	Key Responsibilities	Metrics of Success
JD-001	Overall company strategy	Supervises sales process, signs contracts, and oversees company strategy, including sales.	Achievement of sales targets; contract success rate
JD-002	Sales leadership and strategy	Lead sales efforts, coordinate business development team, manage contracting, and sets pricing and sales strategy.	Sales growth percentage; lead conversion rate
JD-003	Product compliance and development	Oversees product development, ensure compliance with medical device regulations, and integrates client requirements.	Compliance rate; product delivery timelines
JD-004	Regulatory compliance and quality assurance	Ensures regulatory and quality compliance for products, manages quality control, audits, and certifications.	Number of compliance audits passed; quality incident rate
JD-005	Technical integrity and safety	Manages technical aspects of product development, ensuring compliance with regulatory frameworks for medical devices.	Technical issue resolution time; compliance adherence
JD-007	Technology strategy and innovation	Leads technology strategy, oversees technological development, and implementation, and supports innovation and operational efficiency.	Project completion rate; technology uptime
JD-008	Lead generation	Identifies and qualifies leads for the sales team, manages prospecting, and builds the sales pipeline.	Number of qualified leads; sales pipeline growth
JD-011	Brand messaging and public relations	Manages internal and external communication, branding, PR, and content creation to maintain corporate image and messaging.	Engagement metrics; brand recognition levels
JD-012	Executive support	Provides administrative support to the executive team, manages schedules, organizes meetings, and handles communications.	Efficiency of administrative processes; executive satisfaction
JD-013	Project plan, execution, delivery and monitoring	Plans, executes, and oversees projects, ensuring they are on time, within scope, and budget, coordinating resources and departments.	Project completion on time and budget
JD-016	Customer satisfaction and retention	Supports customers throughout their journey, focusing on product adoption, satisfaction, retention, and achieving customer goals.	Customer satisfaction score; retention rate
JD-019	Growth and market expansion	Identifies growth opportunities, builds partnerships, and expands company reach into new markets, driving long-term revenue growth.	Revenue growth from new markets; partnership success rate

Development

Customer classification

We have clients in diverse segments. We group our customers across three parent categories because each group has different goals.

These are our customer segments:

However, care providers can also be classified across two dimensions, depending on their profit status, and depending on the continuity of care, like this:

As a result of the possible combination, the customer segments are the following:

Procedure

Quotation request

The process begins with the communication by a client of their interest in the product.

The JD-002 or their designee will analyze the request individually and will send a specific quotation. The quotation will be prepared using the templates T-009-002 Quotation for API or T-009-004 Quotation for Clinical Trials, depending on the nature of the request.

In the product description published on the website or with the information shared with the customers, a description shall be included to provide the customer with sufficient information to guarantee the understanding of the product. It will also include the reference regulation on which the product is based on and any other applicable aspects.

Quotation preparation methodology

The JD-002, or their designee, prepares an economic proposal where the sales conditions are communicated in response to the received request.

The quotation will be prepared using the templates T-009-002 Quotation for API or T-009-004 Quotation for Clinical Trials, depending on the nature of the request.

Quotation review & change request

The following scenarios are possible:

• If the client accepts the quotation, a service contract is reviewed and signed between both parties and the provision of service begins as described in the Procedure GP-011 Production and service provision.
• If a modification is requested after the provision of service has begun:
  • If it is possible to make the change without prejudice to the process, confirmation from the JD-003 is required, and the JD-002 will confirm to the client that it is possible by canceling the previous budget and sending a new one.
  • If it is not possible to make a change without prejudice to the process, confirmation from the JD-003 is required, and the JD-002 will confirm to the customer that the change is not possible, continuing or cancelling the provision of service. In case of cancelling the contract service, the JD-002 will decide the costs attributable to the client.

Implementation phase

Instead of a production phase, it's more appropriate to the software nature of the device to think about its implementation. Therefore, this procedure defines the Implementation phase.

Implementation starts after the customer has contracted the service, and it includes completing the contract and further documentation process, providing the customer with the required information and providing access to the software or advancing with the predetermined steps of offering a specific service. This is very related to the procedure GP-011 Provision of service, where we explain how we grant customers access to our device.

The contract signed between us and the customers includes a clause in which the customers declare that they are healthcare providers.

To facilitate a successful implementation, we sometimes record the metrics and the timeline for implementation, following the template T-009-001 Implementation plan. These records, ideally but not necessarily, are signed by both us and the customer, as a means of ensuring that the goals are correctly identified.

These records are named following the structure R-009-001 Name of customer YYYYMMDD. These records deviate from the general convention because of the necessity to quickly identify the customer and the date of the contract it refers to.

Distributors traceability agreement

When there are commercial agreements with distributors, a traceability agreement will be generated to specify the conditions and the collaboration commitments of both parties. The traceability agreement will contain, at least, the distributor's commitment to maintain traceability, communicating and facilitating to us the user's contact details and the information received if any incident or malfunction of the products is detected.

When an incident appears in the distributor activities phase, a T-006-001 Non-conformity report is generated after its communication that is managed as it is described in the Procedure GP-006 Non-conformity. Corrective and preventive actions.

Training and information required by clients

If our clients require specific training or more information to guarantee the correct use of the product, we will provide it without unjustified delay, updating the product risk management according to the Procedure GP-013 Risk management if it is required.

In this case, we will be able to carry out an individual training session with the client that requires it to complement the webinars that will be organized in a planned and periodic way. The communication of these training sessions will be done through the website.

Pre-sales

Answering customer's technical questions

This workflow outlines the process for handling customer technical questions or issues within a structured internal system.

It begins with the deal owner evaluating the inquiry and deciding on the best mode of response. If the necessary information is available, the deal owner responds directly. If not, the deal owner gathers context and escalates the task to the project manager.

The project manager, with possible consultation from relevant departments, develops a solution and communicates it back to the deal owner. After review and adjustments, if necessary, the deal owner provides a final response to the customer. This ensures responses are accurate, aligned with business objectives, and involve key stakeholders when needed.

• ⬤ JD-019 or JD-002 Deal owner
• ⬤ JD-013 Project Manager
• ⬤ Other Departments

Post-sales

We also call post-sales activities Customer success. This term represents a more proactive and strategic approach to ensuring customers achieve their desired outcomes when using a product or service.

The following workflow outlines the internal process for handling customer inquiries or issues, starting with an evaluation by the JD-016 Customer Success Manager.

Depending on the nature of the inquiry, the request is directed to the appropriate team. General inquiries are handled by the JD-016, while more specialized issues are forwarded to the relevant departments.

• ⬤ JD-016 Customer Success Manager
• ⬤ JD-019 or JD-002 Deal owner
• ⬤ JD-013 Project Manager
• ⬤ JD-021 Account Manager

For medical device-related complaints, we follow GP-014 Feedback and complaints. Likewise, for new requirements, we follow GP-012 Design, Redesign and Development.

Things we sell

We may only have one product, but it can take the shape of different solutions. Different customer segments may use it in different ways, to solve different problems.

The following chart illustrates a bunch of different things that clients may want to buy from us - although it is the same product; and it also contains links to deals in which we sell each value proposition.

Not exauhstive

This list is not exhaustive, and we may sell our product in ways that are not listed here. This is just a way to illustrate the diversity of our sales.

Diffentiation

Our product is unique in the market because it provides the following features:

• Differential diagnosis for hundreds of conditions
• Severity measure (automatically fill-in the scoring system)
• Regulatory approval and certification
• DIQA: automatic quality control of images

If a customer is comparing alternatives to our product, we can provide them with this list of requirements so they can compare the features of our product with those of the competition. It is unlikely that any other product in the market will have all these features.

Activity dashboard

In the following dashboard, you will find some real-time information about our sales in terms of product usage. Some of the data is estimated and may not be accurate, because customers may not provide data on patients and practitioners when using the API.

Outputs

• T-009-001 Implementation plan
• Sales proposals
• Sales contracts

Associated documents

• T-009-001 Implementation plan
• T-006-001 Non-conformity report
• GP-006 Non-conformity. Corrective and preventive actions
• GP-011 Production and service provision
• GP-013 Risk management

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001