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Design & Development, Medical Device

Design Considerations for Electrical Safety in Medical Devices

As technology improves, this presents new complexities and hazards to the system.  Therefore, medical electrical equipment must be compliant with applicable standards to protect individuals within medical facilities from potential electrical harm.

Medical Device, Risk management

Video | Risk Management in Medical Devices

What is Risk Management? Here is a beautiful presentation to help you understand what Risk Management in Medical Devices looks like in compliance with ISO 14971; the standard for the application of risk management to medical devices.

Medical Device, Risk management

ISO 14971 Let’s Go! The Ultimate Guide to Risk Management in Medical Devices

Risk Management is defined as the “systematic application of management policies, procedures and practices to the tasks of analyzing evaluating controlling, and monitoring risk” Basically, risk management means the right people doing the right activities at the right time to prevent harm.

Design & Development

“Your Design Input Specification is important beyond regulatory compliance”

An insufficient or incomplete design input specification (DIS) can lead to a host of problems and create a big mess. A design input specification is a design control requirement for medical devices seeking regulatory approval.  According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable.   Ambiguity leads to poor design inputs. … Continue reading “Your Design Input Specification is important beyond regulatory compliance”

Design & Development, Medical Device

Video | FDA’s MAUDE database: A medical device expert’s insight

https://youtu.be/OS2unSk68KQ   The Manufacturer and User Facility Device Experience, or MAUDE, database is a tool that I use to help discover potential hazards when developing design input specifications for medical devices. It's very useful and I highly recommend this resource. Here is a simple guide I made to get your search started.       … Continue reading Video | FDA’s MAUDE database: A medical device expert’s insight

Design & Development, Medical Device

How to turn User Needs into Design Specifications (with tables)

Creating your design input specification (DIS) should be the first stage of any product design process. It is a vital tool your Design Team will use as the framework for the design and development of your medical device, and to also comply with regulatory requirements. Wait! Just what is DIS? In the simplest terms, your… Continue reading How to turn User Needs into Design Specifications (with tables)

Design & Development, Innovation

KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs

A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs

Productivity, Startups

Don’t get Bogged: Proven Strategies for Startups to Maintain Productivity Levels

Don’t drain the bog; change the thinking. Getting bogged down is common in busy startup Medtech companies and in bigger, well-established companies too. However, established companies usually spend much less time being bogged down than start-ups. Why?  Because they have more experience being bogged down, so they have developed methods to steer clear of “the… Continue reading Don’t get Bogged: Proven Strategies for Startups to Maintain Productivity Levels

Productivity, Self-help

Medtech Startups: Stuck? These Expert Tips will get you Back on Track

You’re sick and tired of being sick and tired.  You gave it all you can… with all that you have… but you’re still stuck.  Frustrating!  In the last entry, we left to get some energy back and some clarity.  Now let’s get you out!