Usually, a new medical device starts with an idea. Idea created by an engineer who works in the industry or a medical personnel/clinician who found a new solution for an existing problem or a new way
Corrective and Preventive Action (CAPA) – The three most common mistakes
Are you familiar with the CAPA process? Having a Corrective and Preventive Action (CAPA) process is a mandatory requirement of most Quality Management Systems standards. If used correctly,
MDR/IVDR Update
A Call out to all self-certified Class I Medical Device Manufacturers Are you a self-certified Class I Medical Device Manufacturers? In the case of Up-classification under MDR/IVDR, after 26th of May
Changes to MDD commence soon
Do you plan to submit a new MDD submission? Is your current CE certificates under the Medical Devices Directive (93/42/EEC) is due for renewal? You need to take immediate action to meet the
FDA guidance on Medical Devices with Animal origin materials
FDA releases final guidance on Medical Devices containing materials of animal origin. FDA guidance PDF
ISO 13485:2016 transition period ending
As per TGA reminder, ISO 13485:2016 transition period ends on 1 March 2019. From 1 March 2019, conformity assessment applications must be supported by evidence that a quality management system has
Design for new product safety marking in UK
UK Government published the design for the UK marking that would apply to certain products sold in the UK if the UK leaves the EU without a
Urgent BREXIT Implications for Market Access
BSI press release - Urgent BREXIT Implications for Market Access. BSI strongly recommend manufacturers migrate their existing BSI UK NB (0086) CE certificates to BSI NL NB (2797) as a matter of
Medical Device Single Audit Program (MDSAP)
As an outcome of the Medical Device Single Audit Program (MDSAP) Pilot, FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections.