Top Ten Tips + 1 for Medical Device Outsourcing
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
In the face of new potentials and new demands in the health care space, as well as the digitization of daily life, the health care industry is feeling significant pressure to reinvent itself and keep up. The digital transformation of health care is imminent.
How can regulatory engineers help integrate regulatory requirements into the design and development process?
Production and Process Controls – Thinking About Quality
Quality should be considered at all stages of production, starting at the earliest stages of product design, says Dr. Vinny Sastri, President of Winovia LLC. Quality System Regulations Series Reports Sponsored by
Meeting Your Electrical Safety and Quality Requirements
Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.
Controlling Costs in Medical Device Development
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Whether you are thinking about Annual Planning or Year End Closing, we are in a time of reflection and resolve to improve. Over the years I have learned to choose a limited number of improvement efforts, apply management resources, then measure with them regularly for progress and impact. The costs of not focusing sufficiently in a few key areas can ruin a great idea.
Ask the Engineer: A Discussion on Fourslide Forming
What is Fourslide forming, what are some advantages it offers to medical device component manufacturers, and why is it ideal for certain types of manufacturing? A discussion with experts from Acme Monaco .
The Changing Healthcare Ecosystem and a “Systems Thinking” Approach
Systems thinking is a disciplined way of thinking beyond the traditional boundaries of a product, and considers the complete flow of information or activities across a cooperating set of systems and human interventions to complete an intended job. For healthcare, this includes the span of activities for people, devices, information systems, and processes needed to meet various clinical and home healthcare scenarios.
Swift, frequent prototyping and testing, combined with tightly-integrated design and engineering, can help guide your project from opportunity identification, through market release.
