Sop Sales

SOP Sales
Regulatory Requirement Document Section

Medical Device Regulation Article 7 All
ISO 13485:2016 7.2 All
Summary
This SOP describes how we offer and sell our medical devices, including trial and research
projects. With this SOP we want to make sure that we only offer medical devices and
services we develop, and that we sell medical devices/services that comply with regulatory
requirements.
Process Owner <enter role of process owner>

Key Performance Indicators <enter KPIs to be tracked for the Management Review>
1. General Considerations
1.1 Marketing Material
On the basis of its technical documentation, the Sales team compiles the product Marketing
Material. The Marketing Material refers to all claims regarding the functionality, usability
and performance of the medical device. It has to be reviewed and approved by the PRRC
and QMO prior to use. The Sales team is responsible for keeping it up to date.
1.2 Company Product Portfolio

The organisation’s product portfolio, in the scope of sales and marketing, is defined as all
products and services that are released for sales following the software development and
product certification and registration process.
1.3 Special Requirements for Client-Facing Roles

Following national provisions for the German market, every person working in client-
facing roles must obtain training as a Medical Device Consultant.
Optionally, the following provisions may be added:
• Specification of a CRM tool and how it should be used.
• Specification on how to store and manage customer-related information. For example,
use one Google Drive folder for all information related to the same customer.
2. Process Overview
2.1 Compilation of Marketing Material for Medical Device
On the basis of its technical documentation, the Sales team is responsible for compiling the
product Marketing Material and for keeping it up to date. Both PRRC and QMO must
approve the Marketing Material prior to use to ensure that:
• The information is compliant with regulatory requirements for the country in which
the Marketing Material is used.
• The information is consistent with other relevant documents of the technical
documentation, in particular the device’s intended use, risk management, clinical
evaluation and user manual.
Whenever the technical documentation is updated following the change management
process, the Marketing Material must be reviewed for necessary changes.
Participants Sales team

Input New released medical device
Output Released marketing material
2.2 Marketing of Medical Device

Before a marketing event (e.g. presentation to a customer, conference or other external
event), event-specific, product-related claims must be checked for compliance against the
Marketing Material. The responsible employee therefore obtains approval from the leader
of the Sales team or the QMO. Approval must be given in written form (electronic
communication is sufficient), documented and archived.
Participant Any employee

s
Input Draft of specific marketing material (e.g. presentation, flyer, posters, etc.)
Output Approved specific marketing material,Documented approval
Optional:
Add process step(s) for lead management: how to generate, qualify and contract B2B leads.
How to exchange and where to store customer information. Define customer information: also
include informal meetings, phone calls, etc.? What information must be documented at
minimum? Are NDAs required and if so, when?
2.3 Compilation of Customer Contract / Offer

Note: this applies for B2B-customers only and must be customised to your company setting
In case of a portfolio-based request:
The Sales team evaluates the organisation’s capacities to carry out the customer project
(e.g. capacities of service provision, product delivery and maintenance, et.c). Confirmation
by the Management may be requested. If deemed sufficient, the Sales team compiles an
offer / contract. If not deemed sufficient, the project is terminated and no offer / contract is
extended.
Any offer / contract is submitted to the customer in written form (e-mail is sufficient) and
is documented in <specify tool here>. Differences between the customer request and the
contract / offer should be pointed out specifically.
In case of a non-portfolio, new medical device request:
If the customer requests a medical device (feature) which is not part of the existing
portfolio, the Sales team consults with the Management if new development efforts should
be taken into consideration. If not, the project is terminated and no offer / contract is
extended.
If new development efforts are deemed acceptable, the Sales team requests instructions
from the development team and the QMO on how new customer requirements should be
collected.
The Sales team compiles a customised offer / contract that must be approved by
Management and the QMO. Approval must be documented. The offer / contract is
submitted to the customer in written form (e-mail is sufficient) and is documented in
<specify tool here>. Differences between the customer request and the contract / offer
should be pointed out specifically.

Input Customer request
Output Submitted and documented
standard or individual offer
2.4 Closing Customer Contract and Key Account Management

Once the customer accepts the contract / offer, a signed copy is stored on <specify tool
here>. The Sales team appoints a responsible person to serve as the main point of contact.
This person is communicated to the customer. The deployment process is initiated.

Input Submitted standard or customised
offer / contract
Output Deployment process initiated
2.5 Handling Feedback

The Sales team proactively reaches out to customers to obtain feedback. All customer
feedback is handled following the organisation’s feedback management process.
The vigilance process must immediately be initiated for any customer complaint related to:
• a problem with the medical device that could cause or may have caused or did in
fact cause a death or serious deterioration in the state of health.
• a problem with the medical device that significantly impaired the performance
criteria of the device (based e.g. on the information given in the intended use, user
manual or marketing material).
A serious deterioration in state of health results in at least one of the following:
• life-threatening illness or injury
• permanent impairment of a body structure or a body function
• hospitalisation or prolongation of patient hospitalisation or a condition which
requires medical or surgical intervention to prevent any of the above
• chronic disease
• any indirect harm as a consequence of an incorrect diagnostic result when used
within manufacturer’s instructions for use
Input Running customer project
Output Initiated feedback management or
vigilance process
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SOP Sales

Regulatory Requirement Document Section

Process Owner <enter role of process owner>

1.2 Company Product Portfolio

1.3 Special Requirements for Client-Facing Roles

Participants Sales team

2.2 Marketing of Medical Device

Participant Any employee

2.3 Compilation of Customer Contract / Offer

Participants Sales team

2.4 Closing Customer Contract and Key Account Management

Participants Sales team

2.5 Handling Feedback

Template Copyright openregulatory.com. See template license.

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