Navigation Links
Orthogonal Obtains ISO 13485 Certification for Medical Device Software
Date:10/9/2017

Orthogonal, LLC, the leader in companion software development for medical devices, today announced it has been successfully certified according to ISO 13485:2003, the international standard for medical device quality management systems. The certification bestows official recognition on the company for its agile enabled quality management system governing software product design, development, testing, enhancement and support for medical device software.

Orthogonal was awarded certification by BSI, one of the world’s leading certification bodies/registrars offering the latest in management systems certification services.

“Today’s medtech environment presents new challenges and opportunities for medtech innovators,” said Bernhard Kappe, CEO of Orthogonal. “Sensors, connectivity, smartphones and cloud computing are evolving at ever increasing speed, and the FDA, payers and providers are demanding more and more real-world evidence to support value-based care. We’ve built and battle-tested our processes to specifically address these challenges, by integrating user experience design, agile methods and testing automation to deliver quality at speed. Obtaining ISO 13485 certification further confirms that we can provide our customers with innovative solutions that are in full compliance with their requirements and those of the FDA and global regulators.”

About ISO 13485:2003:
ISO 13485:2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.

About Orthogonal, LLC
Orthogonal is a company specializing in connected medical devices and mobile and cloud companion software. Based in Chicago and San Francisco, Orthogonal develops Class I, II and III software as a medical device (SAMD) systems in a broad range of areas, including cardiology, diabetes care, neuromodulation, drug delivery and orthopedics. Orthogonal applies agile practices, test automation and user experience design within an IEC 62340 and IOS 13485 compliant quality management system to build FDA cleared and CE marked systems for patient adherence, continuous monitoring, early detection and prevention, personalized therapies and chronic condition management.

Read the full story at http://www.prweb.com/releases/2017/09/prweb14713870.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. Orthogonal Announces the Opening of their New Office in San Francisco’s SoMa Neighborhood
2. Kyowa Hakko’s Citicoline Obtains Novel Food Registration status in Europe
3. Healthpointe Obtains a New Medical Clinic in the LAX Area
4. Doctor Lisa Maturo of Maturo Medical Obtains Expert Certification in BioIdentical Hormone Replacement Therapy from World Link Medical
5. Gersowitz Libo & Korek, P.C. Obtains a Favorable New York Supreme Court Ruling To Allow a Film Crew Member to Proceed With His Case Under New York Scaffolding Law
6. DiaCarta Obtains Exclusive License for Non-Invasive Early Detection Colon Cancer Test
7. Chesapeake Regional Medical Center Obtains First da Vinci® XI Robotic Surgical System in Virginia
8. BIOMATLANTE obtains CE approval to market its OSTEOTWIN™ Affix Sheath
9. Skilled Psychologist of Healthpointe Obtains Post Doctoral Masters Degree in Clinical Psychopharmacology
10. BIOMATLANTE Obtains CE Approval to Market EZ Cure Plug and Strip
11. M&S Technologies, Inc. Obtains CE Certificate of Conformity to Further Strengthen its Commitment to the Vision Testing industry.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Dickinson Insurance and ... and financial preparation services, is providing an update on a charitable event that ... City Rescue is a locally recognized nonprofit that provides shelter and care for ...
(Date:10/13/2017)... , ... October 13, 2017 , ... While it’s often ... a problem. Fortunately, an inventor from Austin, Texas, has identified a solution. , She ... in darkness or restricted lighting. As such, it eliminates the need to turn on ...
(Date:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, ... guideline updates for the primary prevention of cardiovascular diseases during the 15th ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 11, 2017  BioPharmX Corporation (NYSE MKT: BPMX) researchers ... an innovative way to use nonlinear optical imaging to ... new drugs. ... will show how researchers from BioPharmX and the Wellman ... used a suite of imaging techniques in what is ...
(Date:10/11/2017)... CHICAGO , Oct. 11, 2017  Hill-Rom Holdings, ... its Aspen Surgical facility in Las Piedras, ... surgical scalpels and blades. ... confirmed that the facility sustained minor structural damage, temporary ... Hurricane Maria. Repairs have been completed, manufacturing operations have ...
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
Breaking Medicine Technology: