The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.
Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices.
In today’s complex and constantly changing medical device world, it is more important than ever to fully understand regulations — particularly those regarding communication with Notified Bodies — to be able to comply with quality and regulatory requirements in Europe.
As a result of the European Union's new Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) adopted earlier this month, many adjustments will be required in the roles and responsibilities of medical device companies, manufacturers, importers, distributors, and authorized representatives.
The MEDDEV guidance 2.71, revised by the European Commission this year, instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up.
By incorporating risk management in the quality policy, the organization basically is adopting a preventive action approach to most activities performed under its quality system, a practice in alignment with the latest ISO 13485:2016 expectations. Risk management can be used after policy implementation for continuous improvement, as well.
The Medical Device Single Audit Program (MDSAP) pilot is nearing its end and the 2017 MDSAP implementation is looming. While still viewed with a certain degree of suspicion, the program likely will become the new model to follow for most medical device manufacturers selling internationally. Read on to learn how your company can thrive in the new regulatory landscape this program will create.
The International Organization for Standardization (ISO) is revising ISO 13485, the international quality standard for medical devices. The final version is set for release early in 2016, and here we summarize the final draft's proposed changes to help you prepare for its publication and enforcement.
In Part 1 of this series, we discussed developing a risk management strategy for supplier evaluation, along with a qualification plan to demonstrate compliance to auditors/regulators. In this article, I will share best practices for implementing a successful risk-based supplier management system, as well as explain the requirements that should be clearly defined in a supplier quality agreement.