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P. 13
Regulatory Affairs News
SCC’s MDSAP/ISO 13485:2016
certification inspection is complete
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 possible level of customer satisfaction and patient safety.
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 an MDSAP-approved
auditing organization.
• The stage 1 audit took place at the end of December (remote) and mid-January (on-site).
This audit focused on ensuring that procedures are compliant with MDSAP requirements.
• The stage 2 audit took place in mid-February (on-site). This audit focused on ensuring
that procedures are being followed by inspecting our records for objective evidence.
• On February 13, 2019, SCC concluded the six-week inspection process
to obtain ISO 13485:2016 and MDSAP certifications.
The lead auditor has recommended SCC for certification. Final certification will take approximately
four to six weeks. This accomplishment will enable SCC to proceed with our global expansion
without the hindrance of further disparate regulatory requirements.
We look forward to announcing the final results of this audit in the near future.
ISO 13485 is the international standard for medical
device manufacturers. In the U.S., we have always focused
on 21 CFR 820. Most of the rest of the world uses ISO 13485.
MDSAP (or Medical Device Single Audit Program)
is based on ISO 13485, but also includes specific
requirements for the U.S., Canada, Australia, and Brazil.
As such, these countries accept MDSAP certification
in lieu of requiring inspections by each country,
and MDSAP audit results are reported
to each of these countries.
