OBSERVE MEDICAL ASA | ANNUAL REPORT 2024
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In our efforts to identify and manage
sustainability risks and opportunities, we also
recognize the growing importance of regulatory
frameworks aimed at improving transparency
and responsible business practices. The
Norwegian Transparency Act, which came into
effect on July 1, 2022 mandates large
companies with operations in Norway to
conduct due diligence on human rights and
transparency in their supply chains, ensuring
that they are not complicit in human rights
violations or adverse environmental impacts.
The Norwegian Transparency Act places a
significant emphasis on responsible sourcing
and supply chain transparency. For businesses
like ours, this provides an opportunity to
enhance our sustainability practices by
ensuring that we uphold human rights, avoid
corruption, and address any negative
environmental impacts across our value chain.
As view this as an opportunity to align with
global sustainability standards, reinforce our
commitment to ethical practices, and
strengthen the trust of our stakeholders,
customers, and investors
Our key considerations include:
• Supply chain risks: Ensuring that our
suppliers adhere to our high standards of
social and environmental responsibility.
Failure to identify or address risks in our
supply chain, such as labor exploitation,
poor working conditions, or environmental
harm, could result in reputational damage,
legal penalties, and reputational damage.
• Regulatory changes: Keeping pace with
global and local regulations on
sustainability, such as carbon pricing, waste
management laws, and labor standards.
• Climate change risks: Potential impacts of
climate change on our supply chain,
operations, and market conditions.
We actively work to mitigate these risks and
leverage opportunities that align with our long-
term sustainability goals.
P R O D U C T S A F E T Y
Product safety is fundamental to Observe
Medical and is part of the company’s license to
operate. Risk management is applied within the
group to ensure only products with acceptable
risks are placed on the market. The most likely
health and safety hazards are related to human
error when using the products, and the
company therefore works continuously with
usability.
The Quality Assurance and Regulatory Affairs
(QA/RA) director (the role is currently covered
by the CDO) has overall responsibility for
product safety. The QA/RA director is further
responsible for ensuring that Observe Medical’s
products comply with rules and regulations for
medical devices in the markets where the
products are launched.
Observe Medical has a digital group Quality
Management System (QMS) that covers
development, manufacturing and sales of
medical devices in all legal entities and sites
within the group, and has been designed to fulfil
the requirements in the Medical Devices
Directive (MDD), Medical Device Regulation
(MDR), applicable parts of 21 CFR, including
but not limited to Part 820 (QSR), and EN ISO
13485:2016. The QMS at Observe Medical
holds a Certificate of Registration on that the
QMS has been registered by Intertek (0413) as
conforming to the requirements of SS-EN ISO
13485:2016. The certified scope is;
“Developing, manufacturing and sales of
medical device systems for managing and
measuring of body fluid”.
Observe Medical has established its own
Quality Manual, which describes the overall
structure, content, and purpose of the
company’s Quality Management System
(QMS), as well as Quality Objectives with clear
responsibilities. The company’s Risk Policy
outlines the criteria for determining product risk
acceptability towards patients and users.
Furthermore, Observe Medical has
implemented a Quality Policy stating the
company’s commitment to complying with
applicable regulatory requirements, laws, and
guidelines, and to ensuring that products are
delivered at the right time, to the right place, and
with the promised quality.
Ensuring high quality products and processes is
a prerequisite for the Group’s contribution to