Page 8 - index
P. 8
Regulatory Affairs News
SCC Soft Computer is MDSAP/ISO 13485:2016 certified
Since 1979, SCC Soft Computer has been committed to the design, development, delivery, support, and
implementation of the safest and most effective laboratory and genetics information systems. Our goal
is to have the highest level of customer satisfaction and patient safety possible. To achieve this, SCC’s
senior management is dedicated to providing the resources and framework necessary to maintain this
level of continuous quality improvement.
As part of SCC’s global expansion and our continued commitment to quality, in May 2018, we embarked
on a mission to obtain MDSAP/ISO 13485:2016 certification. To achieve this certification, an audit was
required, and the company was inspected by Intertek, an MDSAP-approved auditing organization.
On March 24, 2019, SCC achieved ISO 13485:2016 and MDSAP (Medical Device Single Audit Program)
certification. This is significant because SCC Soft Computer became certified as a medical device
manufacturer held to new standards of higher product and service qualities, as well as higher
regulatory requirements.
What does this mean to SCC Soft Computer?
As of January 1, 2019, the specified MDSAP countries accept the ISO/MDSAP certification in order
to execute country-specific medical device manufacturer requirements (registration, marketing, sales,
distribution, etc.). On March 24, 2019, SCC Soft Computer began pursuing international expansion in
the MDSAP-participating countries and either continued or completed our international expansion with
non-MDSAP-participating countries as our international expansion and quality program proceed.
What is ISO 13485:2016?
This is the international standard for medical device manufacturers.
SCC Soft Computer has demonstrated our ability to provide medical devices and related services that
consistently meet quality, customer, product, service, continuous improvement standards, and applicable
regulatory requirements.
What is MDSAP?
The Medical Device Single Audit Program incorporates the structure of ISO 13485:2016, but integrates
specific product, service, and regulatory requirements of participating MDSAP countries.
At the current time, the MDSAP countries that currently apply to SCC Soft Computer are Australia,
Brazil, Canada, and the United States.
As MDSAP expands, SCC Soft Computer will continue to add countries and organizations that become
MDSAP participants such as the European Union (EU), which is currently an Official Observer.
SCC Quarterly | Volume 5 • Issue 2 | Regulatory Affairs News
