gMendel receives ISO 13485 certification and gets ready to launch Phivea® platform - #BHHMembersInitiatives
Become a member
About us
Overview The Team Ambassadors Location & Contact Get your office at the Hub
Members
Members Become a member
Events
Next events Past events ISE 2026 4YFN 2026 Health Revolution Congress Organize your event at BHH
Reports
Digital Health Reports Programa Jovenes Investigadores
e-health validations
News
Recinte Modernista de Sant Pau
Carrer de Sant Antoni Maria Claret 167
08025 Barcelona, Spain
Home News gMendel receives ISO 13485 certification and gets ready to launch Phivea® platform - #BHHMembersInitiatives
Back

gMendel receives ISO 13485 certification and gets ready to launch Phivea® platform - #BHHMembersInitiatives

MARCH 21, 2022 Members' News
BHH member gMendel, a Danish biotech company aiming to transform the diagnosis of genetic disorders for better disease management, is now certified with ISO 13485, within the scope “Design and Development and Service Provision of In Vitro Diagnostic Medical device software”. Following this great milestone, gMendel is now legally entitled to commercially launch version 1.0.0 of Phivea®Platform, the novel screening tool for the detection of Klinefelter syndrome. The ISO 13485:2016 specifies the 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.  The ISO 13485:2016 certification demonstrates gMendel’s commitment to providing high-quality and consistent products and services to its clients. Currently, the company is preparing for the 2017/746 IVDR. Barcelona Health Club and gMendel partnered in 2021 under the common vision to accelerate digital transformation in healthcare and advance the efficient uptake of new healthcare technologies in the European regulatory and legislative framework.   Read the full article here. 
You may also like
 See all
October 05, 2026 Members' News
MSD in Spain joins Barcelona & Madrid Health Hub to drive digital health innovation
MSD in Spain has signed an agreement to join Barcelona & Madrid Health Hub, taking another step forward in its commitment to digital health innovation, an area in which the Company has been working for some time.
Read more
September 21, 2026 Members' News
Sykah introduces virtual workers that eliminate administrative burden from pharma companies
Today, in most plants, admin work eats the real work. Incident reports on paper. Data copied by hand between excels. Hours of process documentation nobody has time to maintain. The result: skilled technicians doing office work, and decisions made late or on incomplete information.
Read more
September 21, 2026 Members' News
Skinive expands AI-powered skin analysis platform with new UV Protection & Monitoring features
Barcelona, Spain Skinive, a member of Barcelona Health Hub, has announced a major update to its AI-powered skin health platform with the launch of new UV Protection & Monitoring features for iOS and Android. The latest release helps people better understand daily ultraviolet (UV) exposure and make more informed decisions about sun protection during periods of high UV radiation and extreme summer temperatures.
Read more
September 11, 2026 Members' News
AMConsulting Medical Devices will be at Farmaforum 2026
On September 22 and 23, Farmaforum will bring together companies, professionals, and innovative projects from the pharmaceutical, biotechnology, and medical device sectors at IFEMA Madrid.
Read more
September 11, 2026 Members' News
Barcelona Health Hub Member InnHealthium Helps MedTech Companies Prepare for the EU AI Act
Barcelona Health Hub member InnHealthium is bringing together experts in AI-enabled medical devices, standards development, QA/RA and conformity assessment for a dedicated event at Barcelona Health Hub on September 22, helping the MedTech ecosystem prepare for the practical impact of the EU AI Act.
Read more
July 17, 2026 Members' News
IDEA Design reaches a new European milestone in healthcare design
IDEA Design has reached a new milestone in the iF Design Ranking 2022–2026, placing 11th among 76 European design and architecture studios in the Medical/Healthcare category, and ranking as the leading Spanish company in this classification.
Read more
July 15, 2026 Members' News
A Faster Route from Digital Health Idea to Patient Impact
Maze Interactive Health is helping healthcare organisations design,  build and scale intelligent digital solutions without the delay, cost  and complexity of starting from scratch.
Read more
July 15, 2026 Members' News
Time is Brain oversubscribes a €3 million funding round and obtains CE/MDR approval to accelerate the adoption of Real-Time Stroke Intelligence in Europe
Barcelona, Spain – July 9, 2026 – Time is Brain, a pioneer in the emerging category of Real-Time Stroke Intelligence, today announced two key milestones supporting its commercial expansion across Europe: the oversubscription of a €3 million Pre-Series A funding round and the CE/MDR approval of its flagship BraiN20® Real-Time Stroke Intelligence platform.
Read more
July 15, 2026 Members' News
Vall d’Hebron and Barcelona & Madrid Health Hub Renew Their Collaboration to Advance Digital Health Innovation
The renewed agreement will enable both organizations to continue working together to accelerate digital health innovation and support the adoption of new technologies across the healthcare system.
Read more
July 10, 2026 Members' News
Tandem introduces AI-powered clinical decision support for faster, evidence-based care
The new solution enables healthcare professionals to receive source-linked clinical answers in seconds while documenting the patient consultation.
Read more