One of the best tools at our disposal in a quality assurance/quality control context (manufacturing, supplier quality, etc.) is statistics. However, you should use caution and be mindful that you use it correctly and effectively. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, shares his 3 lessons learned.
FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers
Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.
Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management
You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.
7 Rules For Properly Interpreting Control Charts
It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements.
Helium Leak Detection Technology Solves Cold Supply Chain Challenges Of Today’s High-Risk Pharmaceuticals
Vaccines and other large-molecule products require unique storage conditions, especially during the cold chain. Helium detection technology can improve the quality of drug delivery system and container design.
Designing a product with consideration for the manufacturing process can reduce production times and costs, as well as simplify development of transport, storage, and protection solutions.
A global medical device company came to Donatelle for help perfecting a silicon seal component to meet the new ISO 27186:2010 standard. In this case, a seal with micro-features is needed to reliably isolate the four-pole electrical contacts between the pacemaker and defibrillator and fit inside the 6.3 mm medical device.
The success or failure of surgical navigation is mostly influenced by a single aspect: the accurate representation of instrument positioning. Without this, the procedure and safety of the patient could be compromised. Hermetically sealed LED modules enable optical tracking technologies with reliable precision.
Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.
MED DEVICE ONLINE CONTENT COLLECTIONS
As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. Jayet Moon, author of the book Foundations of Quality Risk Management, takes a bottom-up approach to PMS with this e-book.More Content Collections