ISO 20417 – what device manufacturers should consider
The new edition of ISO 20417 has been published, further clarifying expectations for information ...
Custom regulatory and clinical strategy workshops
A strong regulatory and clinical strategy early on can save months of rework later. Our custom ...
Are you our next Quality and Regulatory expert?
We are looking for experienced medical device or IVD Quality Assurance & Regulatory Affairs ...
Investigator-initiated clinical trials
Many important clinical studies start with researchers – not pharmaceutical companies. In ...
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969. The core message is ...
Clinical trials: proposals, budgets, and the evolving CRO role
This podcast episode from Trustful Clinical Budgeting dives into what really makes proposals work ...
A big milestone for the MINT study
After nearly four years of coordinated, hands on work across sites and functions, the MINT study ...
Quality management system according to EN ISO 13485:2016 – in practice
Do you work with medical devices? Understanding and implementing a robust Quality Management System ...
How MoniDose strengthened their regulatory confidence—fast
When MoniDose began their startup journey, regulations were their biggest challenge. Missing early ...