Quality and Regulatory Compliance Consulting | Blog

September 11, 2018
By Rita King
Uncategorized

Advocate v. Adversary: why your perception of the FDA can affect your submission

Ensuring a FDA 510(k) submission is done properly is critical to getting your medical device into the market and monetizing your development. And the speed with which you complete your submission can drive significant business value. Timeliness is key, as is completeness and accuracy. This is the business value we seek to bring to our...

September 14, 2017
By Rita King
Medical Devices

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees...

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA...

August 7, 2017
By Rita King
Company News

MethodSense Named Top 25 Life Science Technology Vendors

CIO Applications recognizes MethodSense as Top Life Science Technology Vendors Amidst technological innovations, regulatory changes, and increased reliance on patient-centric models, there seems to be a multitude of growth opportunities for life sciences companies. Life sciences undoubtedly remain one of the industries that see rapid technological evolution ahead of them. Even though life sciences has...

FDA Issues New List of 510(k) Exempt Medical Devices

New Class II 510(k) Exempt Medical Devices As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and...

July 7, 2017
By Rita King
Company News

CV Magazine Names Regulatory Strategist Female CEO of the Year

Our CEO and Regulatory Strategist, Rita King, was recognized as Female CEO of the Year 2016 by CV Magazine. In addition to the award, CV Magazine conducted an in-depth interview with Rita to find out more about her success leading up to and in her current role at MethodSense. CV Magazine: Tell me about...

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital...

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on...

February 21, 2017
By Rita King
IEC 62304, Life Science Software, Risk Management

Cybersecurity’s Impact on Health Systems

We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient....

How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of...