Regulation changes. Your company needs to know first.
Standards updates, case analyses, practical tutorials and e-books, written by auditing and implementation professionals in medical devices and pharmaceuticals.
Regulatory Radar: What Changed for Medical Devices in August 2026
Regulatory Radar: What Changed for Medical Devices in August 2026
August 2026 brought regulatory movement on four fronts at once. The FDA, the European Union, ANVISA and three Asian authorities all changed the rules in the same month.
Brazil Registration Holder: How Foreign Manufacturers Sell Medical Devices in Brazil Without a Local Entity
ANVISA does not accept registrations under a foreign company's name. Without a legal entity in Brazil, there is no registration, and without a registration, there is no importation and no sales.
A special process is not audit jargon - it is the factory's most misunderstood risk category
If your process output cannot be verified by inspecting the finished product, you are dealing with a special process - where failure does not show up in the component, but in the patient.
ISO 19011:2026: What Changed in the Standard Governing Management System Audits (and Why the New Guidance Already Applies to You)
ISO 19011, the standard guiding management system audits, reached its fourth edition in May 2026. As a guidance standard, it has no transition period and applies from publication. The most significant changes concern remote and hybrid auditing, virtual locations, reliable digital evidence and auditors' digital competence.
Your sterilisation cycle is validated. But did you validate the right product under the right worst-case conditions?
An approved cycle shows that the equipment delivers the process - not that the most challenging device, in the most demanding load, achieves the required SAL. This confusion is one of the sector's costliest gaps.
Hospitalar 2026: HSC Global Connects Brazilian and International Regulatory Partners
HSC Global Group took part in Hospitalar 2026 at São Paulo Expo, connecting Brazilian and international manufacturers to its ANVISA, FDA, EU MDR, MDSAP and ISO 13485 regulatory consultancy services. Over the four days of the fair, the team met industry leaders seeking to navigate Brazilian and international regulatory requirements with confidence.
Packaging does more than protect the product. It maintains sterility - and that takes different engineering
Physically protecting a product and maintaining a sterile barrier throughout its shelf life are distinct objectives requiring distinct validations. Sterility only reaches the patient if the packaging preserves it.
Good Clinical Practice in Brazil in 2026: What ANVISA's New Reports Reveal About the Future of Medical Devices
The clinical research framework for medicines and the medical device regulatory landscape are converging. Those who understand this first enter the Brazilian market with a real advantage.
Four Regulatory Requirements, One Validation System (QMSR, MDR and RDC 751)
ISO 13485, FDA QMSR, MDR 745/2017 and RDC 751/2022: treating each framework as a separate project multiplies costs and weakens your case. The solution is one system interpreted through several regulatory frameworks.
Quality of Evidence in Clinical Evaluation: What Regulators Actually Require
Not all clinical data amounts to evidence. Understanding this distinction is what separates an approved dossier from a deficiency request that brings your registration to a halt.
Class III in Panic, Class II on Alert: The UDI Lesson Your Company Cannot Ignore
A historical scenario on the costs of late UDI planning, preserved with editorial context. Consult current ANVISA requirements before acting.
ISO 10993-1:2025 Has Officially Been Published: The Transformation of Medical Device Biological Evaluation Has Reached Brazil
The sixth edition of ISO 10993-1, the leading standard for medical device biological evaluation, was published in November 2025 and fundamentally changes how biological safety is assessed.