FDA’s 2027 guidance priorities: what medical device teams should prepare for
The 5 October 2026 standards and guidance update: how FDA’s FY2027 priorities can inform medical-device development and lifecycle planning.
Quality & regulatory
Connect QMS and regulatory expectations with proportionate practice and useful evidence.
CSA, Part 11 and QMSR: building a coherent software assurance approach
A practical approach to shared software assurance evidence, with clear regulatory boundaries and a worked calibration-system example.
Which standards apply to an IVD medical device?
Why standards selection for an IVD must follow the complete system, its intended purpose and the consequences of an incorrect result.
Which standards does your medical device actually need?
Why a long standards list is not enough—and how intended purpose, harmonisation and product-specific evidence shape a defensible standards assessment.
Can an unregistered digital health technology be used in a clinical trial?
Why absence of commercial registration does not automatically prevent a digital health technology from being used in a clinical trial—and the questions sponsors should ask instead.
Building an audit-ready design history file
What makes development evidence coherent, reviewable and defensible before an audit or submission.