Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Welch Allyn Regulatory Affairs Director On Consulting, Consultants

This article was originally published in The Silver Sheet

Executive Summary

AS A FORMER CONSULTANT, WELCH ALLYN'S director of regulatory affairs has worked on both sides of the equation. He relates some common misperceptions in industry.

You may also be interested in...



FDA Officials Concerned When Firms Don't Heed Good Consultant Advice

CONSULTANTS CAN HELP DEVICE MANUFACTURERS resolve quality systems problems, but companies don't always follow their consultants' recommendations, FDA officials lament. “The real challenge in working with these consultants and contractors ... is making sure [the recommendations] are sustainable and business-friendly,” says Bill Duffell, senior VP for global quality and regulatory affairs for Gambro Renal Products. The company recently got out from under an import ban imposed by FDA with the help of numerous consultants. “We got to a certain point on some things where we needed horsepower in addition to our own horsepower,” Duffell says. Meanwhile, an industry survey finds that manufacturers tend to pay anywhere from $100 to $250 per hour for independent quality and regulatory advice.

COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers

First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.

Topics

UsernamePublicRestriction

Register

OM013626

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel