Medical Device Design & Development

INDUSTRY PERSPECTIVES

How AI Is A Game-Changer For Auditing Compliance And Efficiency

In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

Struggling With GxP Systems? There's A DAP For That

A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

Key QMS Considerations For Your Medical Device Startup

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and provides information to help you make the right decision for your medical device company.

A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

WHITE PAPERS & CASE STUDIES

Ophthalmic Delivery Systems: Drug And Device Testing For Regulatory And Patient Compliance

Explore ophthalmic drug and device testing, focusing on regulatory and patient compliance, including design considerations, testing methodologies, safety, and efficacy for medical device development.

Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Design Testing Strategies To Develop A Drug-Device Combination Product

Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance

Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.

DESIGN COMPONENTS & SERVICES

Piezo electric steering mirrors provide higher accuracy, speed and acceleration than other steering mirror solutions in a smaller package. They can provide 3 axis motion in one single pivot point design with no polarization rotation. Extremely fast response in the sub-millisecond range is feasible with nanoradian resolution.

AvaLibs Modules by Avantes provide an alternative method of configuring a LIBS system. These modules allow you to choose the number of AvaSpec spectrometers (up to 8), the number of axis in your sample chamber, and the layout. 50 mJ and 100 mJ lasers by Avantes are available, but you also have the option of connecting your own laser to the system (through an available adaptor plate).

The complexity involved in choosing the right biocompatibility testing for medical devices has substantially increased over recent years. In order to successfully move medical devices to market, it is crucial to have experts available to help develop complete submission packages, and to offer the right advice for biocompatibility testing. Industry-recognized scientists at WuXi AppTec are experienced in providing expert guidance to medical device and combination product manufacturers in designing specific biocompatibility programs for their submissions to regulatory agencies worldwide.

Ocean Optics’ Torus miniature spectrometer delivers scientific grade performance from 360-825nm. Torus has a unique toroidal concave grating design for improved thermal wavelength stability and low stray light. Low stray light, high throughput and excellent thermal stability make the Torus ideal for a wide range of demanding research and OEM applications

Hexapod motion systems are based on six high-resolution actuators acting on one platform through a parallel kinematic arrangement. The advantage is a smaller design, with higher dynamics and precision compared to classical multi-axis motion.  A sophisticated controller allows the user to change the pivot point at will.   The bottom line is an extremely versatile motion,  very similar to a human hand, which is why in medical engineering hexapod positioners are often used for handling systems and for surgery and endoscopy. In therapeutics, they allow the patient to be placed in exactly the right position, e.g. for the treatment of a tumor.

Heatron’s Heatflex Kapton® and polyimide etch foil heaters are very thin and feature a flexible circuit design, high dielectric strength, precise heat distribution, low outgassing, and superior tensile strength for medical devices.

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