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SCC Soft Computer™ achieves MDSAP / ISO 13485:2016 certification

July 24, 2019

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SCC Soft Computer
Ellie Vahman
727.789.0100 x4052
ellie@softcomputer.com

Clearwater, Florida – July 24, 2019SCC Soft Computer announced recently that the company achieved ISO 13485:2016 and MDSAP (Medical Device Single Audit Program) certification on March 24, 2019.  With this certification as a medical device manufacturer, SCC Soft Computer will be held to new international standards of higher product and service qualities, as well as higher regulatory requirements.

In May 2018, as part of SCC’s global expansion—combined with the company’s continued commitment to quality, SCC 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.

  • The stage 1 audit took place at the end of December (remote) and mid-January (on-site). This audit focused on ensuring that SCC’s 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, and included an inspection of SCC’s records for objective evidence.
  • On February 13, 2019, SCC concluded the six-week inspection process to obtain ISO 13485:2016 and MDSAP certifications.
  •  SCC was informed on March 24, 2019, that the company had achieved ISO 13485:2016/MDSAP certification.
  • On March 24, 2019, SCC began pursuing international expansion in the MDSAP-participating countries and either continued or completed its international expansion with non-MDSAP-participating countries as the company’s international expansion and quality program proceed.

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,” said Mr. Gilbert Hakim, SCC’s CEO and founder.  “This accomplishment will enable SCC to proceed with our global expansion without the hindrance of further disparate regulatory requirements.

About ISO 13485:2016

ISO 13485:2016 is the international standard for medical device manufacturers.  ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.  It has been revised, with the new version published in March 2016.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.  Such organizations can be involved in one or more stages of the lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support).  Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and type except where explicitly stated.  Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

About MDSAP

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.  Simply put, MDSAP allows an MDSAP-recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.  Effective 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.).

About SCC Soft Computer

SCC Soft Computer is at the forefront of laboratory, genetics, outreach, and blood services information systems software development and offers full suites of Web-enabled laboratory and genetics information system solutions.  Since 1979, SCC has designed, developed, delivered, implemented, and supported powerful integrated clinical information management system solutions for hospitals, large IDNs (integrated delivery networks), and laboratories.

Considered the world’s largest LIS software production house – with a global workforce of more than 2,000 professionals dedicated to LIS development – SCC has experience in accomplishing complex LIS implementations in large, multisite environments.  SCC's flagship product, SoftLab®, has been recognized as the market standard for its robust functionality and ease of instrument interfacing, including robotics.  The company has a history of success in a wide variety of clinical laboratory environments – from commercial and public health laboratories, to university-based teaching environments, to research and clinical trials labs, and multisite health systems with both distributed and core laboratory operations.  Their robust, integrated information systems dramatically increase productivity in the laboratory enabling hospitals of all sizes to optimize their workflows.

Visit http://www.softcomputer.com/ for more information.

About Intertek

Intertek Group is a multinational assurance, inspection, product testing, and certification company headquartered in London, United Kingdom.  An industry leader, Intertek is the largest tester of consumer goods in the world with more than 44,000 employees in more than 1,000 laboratories around the globe in more than 100 countries.  For more than 130 years, companies worldwide have depended on Intertek to help ensure the quality and safety of their products, processes, and systems.

Visit https://www.intertek.com/ for more information.

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