IMDRF Gains Ground with Plans for a Medical Device Single Review Program

International – IMDRF Gains Ground with Plans for a Medical Device Single Review Program

Regulators participating in the International Medical Device Regulators Forum (IMDRF) recently convened in Tokyo to discuss a medical device single review program (MDSRP). The meeting...
Ireland's research center for medtech eyes animal testing facility

Ireland – Ireland’s research center for medtech eyes animal testing facility

Ireland’s research centre for medical devices is to consider developing a national animal testing lab, to trial medical implants on large animals. Cúram, the NUI...
Roche Diagnostics launches cervical cancer screening lab in India

India – Roche Diagnostics launches cervical cancer screening lab in India

Cancer Institute (WIA) launched a molecular lab for cervical cancer screening on Wednesday. Roche Diagnostics India that provides in-vitro diagnostics solutions launched its HPV (Human...
Beta Bionics Wins Readers' Choice for Medtech Company of the Year

International – Beta Bionics Wins Readers’ Choice for Medtech Company of the Year

The people have spoken. Beta Bionics has been named medtech company of the year. Nearly 44% of MD+DI readers participating in a special poll voted for...
Injecting quality into software development with industry-specific guidance on ISO 9001

International – Injecting quality into software development with industry-specific guidance on ISO 9001

ISO/IEC/IEEE 90003, Software engineering – Guidelines for the application of ISO 9001:2015 to computer software, is designed as a checklist for the development, supply and maintenance of computer...
India Adds Four Medical Device Types to CDSCO List of Regulated Products

India – India Adds Four Medical Device Types to CDSCO List of Regulated Products

EMERGO BY UL SUMMARY OF KEY POINTS: India’s CDSCO has expanded its list of medical devices to be regulated. CDSCO’s latest round of additions...
India still lacks comprehensive regulations for medical devices

India – India still lacks comprehensive regulations for medical devices

Thirteen years. That’s how long it has been since a direction was given to the Indian health authorities to have a comprehensive framework for...
Could AI Become the New Quality Control Manager in Medical Device Manufacturing?

International – Could AI Become the New Quality Control Manager in Medical Device Manufacturing?

Quality is of utmost concern to manufacturers everywhere, but perhaps nowhere does it hold greater importance than in the plant where medical devices are...
No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security

International – No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety...

Regulatory focus on medical device safety and risk management intensifying; Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster...
REACH FAQs for Medical Device Professionals

International – REACH FAQs for Medical Device Professionals

REACH stands for Registration, Evaluation, and Authorisation of Chemicals. It is European Union Regulation No 1907/2006. It has many objectives, the most pertinent of...

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