Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • Using Production And Postmarket Data To Validate FMEA Assumptions

    One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending

Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.

Continuity Is The Key To Success For Your Medical Device Company

When your company focuses on improving its bottom line, two common methods are to reduce the size of the workforce or to divest from direct manufacturing responsibility. Also, gone are the days when an employee stays with a company until they retire. As a result of these factors, many medical device companies are losing valuable experience. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, discusses what a company can do to address this knowledge drain.

Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management

The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based postmarket surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.

Tips For Building A Voluntary QA Culture In A 2021 COVID World

As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

WHITE PAPERS & CASE STUDIES

How To Establish High-Quality, Sustainable, Dock-To-Stock Programs

Effective dock-to-stock programs ensure optimal outcomes by identifying risks up front, setting clear timelines, and assigning unambiguous responsibilities to all shareholders.

Quality By Design And Design Control Roadmap For Combination Products

Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

Finding The Ideal Balance – Where Risk And Cost Of Quality Meet

It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

Moisture And Oxygen Risk In The Medical Device Industry

The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. For some devices the ingress of moisture or oxygen over the shelf-life of the product can impact the device performance. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.

DESIGN COMPONENTS & SERVICES

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

Selective laser sintering is an additive process that draws on a bed of thermoplastic powder to create a fully sintered, Nylon-based part. This technique is ideal for parts with highly complex geometries.

The company offers a 0.35 micron CMOS Image Sensors (CIS) process technology.
MicroMo offers a complete range of precision gearheads to complement the extensive line of DC motors. Several different types are available, from high-torque, all-metal planetary gears to highly precise zero backlash gearheads, to fit any miniature motion control requirement...
High-resolution imaging capabilities combined with network communications make the Series 600 SmartImage Sensor a suited smart factory tool
The company, a leading manufacturer of quick disconnect couplings for critical fluid handling, has published a new catalog for bioprocessing, disposable and medical device applications.

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