eBook: Medical Device Development Best Practices

In healthcare technology, innovation, manufacturing, medical device, medtech, operational excellence, product design, product development, Quality by design by GenerisLeave a Comment

With the American Medical Device Summit quickly approaching, we took the time to sit down with one of our industry partners, Stratos Product Development, to gather their thoughts on the biggest medical device development challenges and the best practices to overcome them. Check out the Stratos eBook to explore : Complications arising from a lack of proper documentation, and how to overcome them. Strategies to speed the product development process while effectively managing costs. Tactics to make product launches more predictable. Regulatory considerations that need to be factored into the medical device development process in the U.S. The benefits of outsourcing innovation. eBook, Medical Device Development Best Practices For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.

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Infographic: 5 Mistakes That Can Derail Your Medical Device Development

In innovation, manufacturing, medical device, medtech, mfg, product development by GenerisLeave a Comment

Medical device developers have a series of hurdles they need to navigate in order to successfully bring their device to market.  In today’s infographic, we explore the top five mistakes that can derail the medical device development process and consequently speed to commercialization. Check out the Infographic: 5 Mistakes That Can Derail Your Medical Device Development For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.

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eBook: Traceability Optimization for Medical Device Developers

In healthcare technology, manufacturing, medical device, medtech, product development, traceability by GenerisLeave a Comment

Regulatory bodies such as the FDA require medical device manufacturers to document and track huge amounts of information to ensure device safety and demonstrate that safety in the event of an audit. Given the volume and complexity of information to be tracked, many medical device developers struggle with traceability. We sat down with Seapine Software to better understand the challenges medical device developers face, and how they can be overcome. Check out the Traceability Optimization eBook below! eBook, Traceability Optimization for Medical Device Developers  

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The User Experience for Mobile Medical Apps

In medical device, medtech, product design, product development by Generis1 Comment

“When granting regulatory approvals for medical devices, both IEC 62366 and the FDA have emphasized the importance of applying human factors and user-centered design activities to the development process to ensure medical device safety and improve usability. The development of mobile medical apps is no exception.” – Stratos Mobile  medical apps are becoming widely used as at-home health monitoring and management tools. A key element of an app’s success is its usability and a user friendly design.  Stratos, a trusted resource for science and technology innovators since 1987, has generated the eBook below that outlines the five key steps to ensure a seamless user experience for medical mobile applications.   User Centered Design a Must for Mobile Medical Applications Don’t forget to join Stratos at the American Medical Device Summit 2016 taking place on October 5th – 6th in Chicago!

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Best Practices for Medical Device Development

In manufacturing, medical device, medtech, product design, product development, Qbd, Quality by design by Generis1 Comment

Medical device developers must take into account numerous safety, quality and risk factors to ensure the durability and safety of their devices. Developers must also adhere to strict risk management processes and life cycle requirements that may vary regionally. Our friends at Seapine Software have generated the whitepaper below to help developers navigate this shifting terrain and understand the best practices for exposing risk throughout the product development life cycle.   Exposing Risk Throughout Your Product Development Lifecycle Hear more from Seapine Software by joining the discussion at the American Medical Device Summit 2016!

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Finding the Balance: Compliance, Product Development & Quality Management

In manufacturing, medical device, medtech, mfg, product design, product development, Quality by design by GenerisLeave a Comment

Manufacturers are always looking for ways to speed their time to market and reduce production costs without compromising quality. Those who operate in highly regulated industries also have to ensure that their processes remain compliant with regional regulations.  It can be challenging for manufacturers within these industries to find ways to improve both the product and the development process without compromising compliance.  To help manufacturers navigate this terrain Seapine Software has released the whitepaper below. The whitepaper addresses strategies to achieve efficiency goals by balancing three functional areas: regulatory, development and quality management.  

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