ISO 13485

FPT Software Achieves Double Wins at Healthcare Asia Medtech Awards 2024

Retrieved on: 
Friday, April 5, 2024
Data Management, Health, Technology, Health Technology, Software, Networks, FPT Software, HITRUST, Pharmacy, HL7, AWS, HIPAA, ISO 13485, Multimedia, ISO, DICOM, FPT

Global IT firm FPT Software recently won two categories in the Healthcare Asia Medtech Awards 2024: the Digital Innovation of the Year - Vietnam and the Initiative Award - Vietnam.

Key Points: 
  • Global IT firm FPT Software recently won two categories in the Healthcare Asia Medtech Awards 2024: the Digital Innovation of the Year - Vietnam and the Initiative Award - Vietnam.
  • This marks the second consecutive year the firm has been honored with these awards, solidifying its position as a world-class service provider in the healthcare industry.
  • View the full release here: https://www.businesswire.com/news/home/20240404598004/en/
    Organized by Healthcare Asia, the premier industry magazine catering to hospital owners, investors, administrators, and policymakers across Asia, the annual Healthcare Asia Medtech Awards are designed to recognize and highlight outstanding medtech companies in the region that consistently surpass expectations by delivering groundbreaking innovations to their customers.
  • FPT Software is among over 250 applications this year from businesses across the Asia Pacific region and stands out as the sole nominee from Vietnam to claim two esteemed awards.

EQS-News: After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year

Retrieved on: 
Thursday, February 15, 2024
ISO, Spine, MDR, ISO 13485, Notified body, German, AAP, Elective surgery, EUR, Certification, Health, Guideline, Acceleration, Clinical trial, BMBF, Trauma, MDD, Education, Pharmaceutical industry

After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year

Key Points: 
  • After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year
    The issuer is solely responsible for the content of this announcement.
  • In the past financial year, aap Implantate AG ("aap" or "Company") was able to significantly accelerate patient recruitment with the realignment of the world's first clinical human study for its innovative antibacterial implant technology.
  • Building on these promising developments, aap will continue its efforts to attract significant third-party funding for the industrial expansion of the technology in the 2024 financial year.
  • After a mixed 2023 financial year in the LOQTEQ® trauma division, aap was able to make a positive start to the new 2024 financial year.

Ibex Medical Analytics Achieves HITRUST Certification Demonstrating the Highest Level of Information Protection Assurance

Retrieved on: 
Tuesday, November 14, 2023
Organization, Regulatory affairs, Pathology, Quality assurance, Risk, Certification, Patient, ISO, Laboratory, ISO 13485, HITRUST, University, MD, Diagnosis, Cancer, Hospital, AI, Ibex, UPMC, Marie Cassidy, Medical device

BOSTON, Nov. 14, 2023 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced it has earned certified status by HITRUST for information security.

Key Points: 
  • BOSTON, Nov. 14, 2023 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced it has earned certified status by HITRUST for information security.
  • This achievement places Ibex in an elite group of organizations worldwide that have earned this certification.
  • "HITRUST Certification is globally recognized as validation that information security and privacy controls are effective and compliant with various regulations," said Jeremy Huval, Chief Innovation Officer, HITRUST.
  • Individually, each element exceeds most other programs, and collectively they make HITRUST Certification the most comprehensive, transparent, consistent, and highest quality assessment available."

Sequenex Achieves ISO-13485:2016 Certification

Retrieved on: 
Wednesday, August 23, 2023
Technology, Medical Devices, Venture Capital, Diabetes, Health Technology, Professional Services, Software, Health, General Health, Medical device, QMS, ISO, Internet of things, Collaboration, Software development kit, Certification, International Organization for Standardization, ISO 13485, IOS SDK, Knowledge, Entrepreneurship, International Organization (journal), Safety

Sequenex, a leading digital health and medtech software development firm specializing in the diabetes and connected devices industries, is proud to announce it has received ISO 13485:2016 certification.

Key Points: 
  • Sequenex, a leading digital health and medtech software development firm specializing in the diabetes and connected devices industries, is proud to announce it has received ISO 13485:2016 certification.
  • This important certification validates Sequenex’s commitment to delivering high-quality mobile, cloud and IoT software solutions.
  • By obtaining this certification, Sequenex has demonstrated that its quality management system (QMS) meets all applicable quality requirements and employs robust practices for the design and development of Software as a Medical Device (SaMD).
  • “With this ISO 13485 certification, we further solidify our position as a reliable provider of cutting-edge SaMD solutions for the diabetes and connected devices markets.

Spectral MD Holdings, Ltd. (“Spectral MD” or the “Company”) ISO 13485 Certification Received for AI-Driven DeepView® Wound Imaging System

Retrieved on: 
Monday, August 14, 2023
DFU, AIM, QMS, Culture, ISO, Spectral, SMD, Certification, Organization, Diabetic foot ulcer, Physician, Algorithm, ISO 13485, Artificial intelligence, Quality management system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Wound healing, Medical device, DALLAS, Burn

ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production.

Key Points: 
  • ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production.
  • To receive certification, organizations must demonstrate that their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements.
  • Spectral MD’s receipt of ISO 13485 certification follows the completion of a comprehensive audit of the Company’s QMS undertaken by an Independent Registrar earlier this year.
  • Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: “The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability, and safety.

Spectral MD Holdings, Ltd (“Spectral MD” or the “Company”) Completion of ISO 13485 Certification Audit

Retrieved on: 
Tuesday, June 20, 2023
Medical Devices, Health, Technology, Health Technology, Software, Certification, ISO 13485, Artificial intelligence, AIM, Safety, Spectral, SMD, ISO, Medical device

ISO 13485 certification has now been recommended and is anticipated in Q3 2023.

Key Points: 
  • ISO 13485 certification has now been recommended and is anticipated in Q3 2023.
  • The completion of the audit validates Spectral MD's commitment to meeting the highest standards of quality, reliability, and safety in the medical device industry.
  • The comprehensive audit of the Company’s quality management system was undertaken by an Independent Registrar.
  • Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: “The completion of the ISO 13485 certification audit is a strong endorsement of the quality standards we set at Spectral MD.

An Introduction to the Medical Device Regulation Training Course: In-Depth Insight Into the European MDR Legislation - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 19, 2023
Medical Devices, Health, CE, Medicine, BSI, Medical device, QMS, Classification, Marketing, ISO, Pharmaceuticals and Medical Devices Agency, Writing, European Medicines Agency, UK Notified Bodies, Medication, Notified body, Technical director, Research, European Medical Devices Industry Group, Bachelor of Science, NextGen Healthcare, EMA, MHRA, European, Certification, ISO 13485, Pharmacy, R, Competent authority, Speech-generating device, Test management, Clinical, LRQA, Pharmacist, Nursing, Management

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Key Points: 
  • She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
  • Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
  • Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK.
  • Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

Ada Health Receives EU-MDR Certification for AI-Powered Symptom Assessment Platform

Retrieved on: 
Thursday, December 15, 2022
Certification, Ada Health, Medical Devices Directive, QMS, Public health, Royal commission, Patient, Entrepreneurship, Classification, ISO, SD, Medical device, Notified body, ISO 13485, AI, SSO, European Commission, Ada, Health, IIA, Safety, MDD, EU

NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).

Key Points: 
  • NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
  • The Ada Assess enterprise solution is among the first AI-based symptom assessment platforms to be certified as a Class IIa medical device.
  • To secure Class IIa classification, Ada Health had to consistently demonstrate that its Ada Assess solution, and quality management system (QMS) meet the EU-MDR's rigorous standards for safety and effectiveness.
  • Ada is a global health company founded by doctors, scientists, and industry pioneers to create new possibilities for personal health and transform knowledge into better outcomes.

Ada Health Receives EU-MDR Certification for AI-Powered Symptom Assessment Platform

Retrieved on: 
Thursday, December 15, 2022
Certification, Ada Health, Medical Devices Directive, QMS, Public health, Royal commission, Patient, Entrepreneurship, Classification, ISO, SD, Medical device, Notified body, ISO 13485, AI, SSO, European Commission, Ada, Health, IIA, Safety, MDD, EU

NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).

Key Points: 
  • NEW YORK and BERLIN, Dec. 15, 2022 /PRNewswire/ -- Ada Health GmbH ('Ada Health') the global digital health company focused on improving human health at scale, today announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).
  • The Ada Assess enterprise solution is among the first AI-based symptom assessment platforms to be certified as a Class IIa medical device.
  • To secure Class IIa classification, Ada Health had to consistently demonstrate that its Ada Assess solution, and quality management system (QMS) meet the EU-MDR's rigorous standards for safety and effectiveness.
  • Ada is a global health company founded by doctors, scientists, and industry pioneers to create new possibilities for personal health and transform knowledge into better outcomes.

Greenlight Guru Surpasses 1,000 Customer Milestone and Continues Rapid Growth

Retrieved on: 
Wednesday, December 14, 2022
G2, MDSAP, Medtech, QMS, Letter, Clinical, Deram, Knowledge, Quality assurance, ISO 13485, FDA, Child, Love, Quality of life, Growth, Clinical trial, Risk, CE, Fear, Organization, Risk management

INDIANAPOLIS, Dec. 14, 2022 /PRNewswire-PRWeb/ -- Greenlight Guru, the leading cloud-based platform purpose-built for the MedTech industry, welcomed its 1,000th customer this week, extending its market leadership presence and building on its strong community of customers.

Key Points: 
  • MedTech SaaS Platform continues rapid growth and extends its market leadership in the medical device industry.
  • "We celebrate our 1,000th customer because we know that with each new customer, we have improved the quality of life for real people - a child, a parent, a co-worker, or a friend," says David DeRam, CEO of Greenlight Guru.
  • "Greenlight Guru was instrumental in implementing our quality system," said Maxime Rochon, Manager of Quality Assurance and Design Control at Puzzle Medical.
  • In the coming year, Greenlight Guru expects to continue this rapid customer growth.