Software
[Image from Pixabay]
When it comes to software as a medical device, the regulatory landscape is quite complex.
Premier Research – 2021
Developing software for safety in medical robotics
As healthcare robotics continues to evolve, well-designed software will be paramount to safety and consistent performance.
MedAcuity Software – 2020
Why medical device companies should explore cloud-based product design tools
The move to cloud-based product design tools represents a transformational change, including for medical device creators.
Onshape – 2019
How to ensure safety and security when using mobile devices in healthcare
The emergence of medical IoT and widespread use of wireless technology throughout healthcare has changed the cybersecurity landscape.
Green Hills Software – 2019
How software prototypes can feed your quality system
Achieving regulatory compliance with a new device means more than checking boxes.
Boston UX & Integrated Computer Solutions– 2019
How to make sure an active implantable device will pass regulatory muster
Considering the numerous standards and tests required to get a complex medical device to market throughout the production process will speed that device’s time to market.
Intertek – 2019
10 things to do before your next medical device package validation
Before a medical device package validation, it’s important to do your homework and understand what needs to be done.
DDL – 2019
How to succeed at medtech package validations
Understanding the nuances of package validations and testing — and emerging from the process successfully — is a high-stakes endeavor for manufacturers.
Millstone Medical Outsourcing – 2019
Risk management in sample preparation for device biocompatibility
Having a device tested for biocompatibility can involve several steps, and preparation is key.
Toxikon – 2019
Getting the most out of your lab partnership ahead of the EU’s MDR
Here’s how to make the most of your lab testing partnership in order to avoid costly testing and submission delays as you prepare for the MDR.
WuXi Medical Device Testing – 2019
How to work with a third-party testing lab
Clear communication is key to success when working with any test lab partner. Maintaining good communication and following these tips will help result in a positive testing experience for all.
DDL – 2018
Understanding worst-case conditions in ISO 18562 testing
For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. While adding new device technology and several testing options, weak points remain regarding special cases of externally communicating devices, such as those with gas pathways that carry air or other gases to the lungs.
Nelson Laboratories – 2018
Pre-clinical medical device testing under ISO 10993-1 and the MDR
In today’s changing regulatory landscape, it’s more important than ever for medical device manufacturers to understand the nuances of pre-clinical device testing. Here are the implications of recent and pending regulatory updates, why extractables and leachables testing is more important than ever before, and how you can begin assembling the right team of testing experts to ensure your product portfolio complies.
WuXi AppTec – 2018
Connected medical devices: What are the pros and cons?
What’s the holdup with getting connected medical devices on the market? Here are some potential answers.
Galen Data – 2018
Putting patients first – e-consent in clinical trials
Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs.
Medidata – 2018
How to design for patient safety, data security and reliability
Electronic medical devices are being designed with enhanced and sophisticated functionality, with most of the complexity contained within the software. Many new devices are also equipped to communicate with hospital networks, one another and the IoT (Internet of Things).
Green Hills Software – 2018
The changing landscape of Quality Management Systems
A Quality Management System (QMS) is essential for compliance in medical device manufacture.
EarLens + Omnify Software – 2018
4 ways multiphysics simulation can boost medical device design
From the simulation expert to the device designer, it’s never been easier to access the power of multiphysics simulation.
Comsol – 2017
Middleware: How it’s changing medtech
Medtech developers can take advantage of middleware technology to gain a competitive advantage.
Medical Connectivity Consulting – 2017
