Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Acorn Regulatory streamlines approval process drug-device manufacturers

July 6, 2015 By MDO Editor

Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, is streamlining procedures for U.S. manufacturers of drug-device combinations with customized programs that successfully overcome challenges in meeting European regulatory approvals.

Acorn

Acorn Regulatory will help companies at every stage by determining the correct regulatory pathway for each product; including Notified Body selection and appropriate device classification.

Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical device products that also have a drug component. This process includes training programs that first define the requirements, the steps to obtain CE Mark Certification, post-market responsibilities of manufacturers, national requirements throughout Europe and service as an EU Authorized Representative.

“While our work includes support for large multi-national pharmaceutical and device manufacturers, we have found that, in particular, small to mid-size companies looking for EU certification are often intimidated by the complex steps and potential costs in gaining approvals,” said Dr. Gemma Robinson, managing director of Acorn Regulatory. “To meet that need, we have streamlined the approach with an affordable process and a team with a wide range of experience in different product technologies who can offer a customized approach to gain CE Certification and manage post-approval activities. These processes range from training to Quality Management Programs, report writing, electronic submissions, risk management and service as a European Authorized Representative.”

Companies seeking certification for a drug-device combination can face considerable challenges. Due to complexity and risk, they may be subject to additional directives if devices incorporate a substance of animal origin or human blood derivatives. Drug device combinations must comply with the medical device and pharmaceutical directive requirements, which can be an added challenge to small and medium sized companies who do not have expertise in both areas. Determining a device’s status, whether it be drug or medical device, depends on its primary mode of action.

According to Robinson, the complexity of the process and the proliferation of drug-device products seeking EU certification is exactly why Acorn Regulatory further streamlined its process.

“We have cross-functional teams which can offer both the medical device but also the pharmaceutical know-how to ensure that we can obtain the fastest route to market for our clients products,” said Robinson. “We also have live access to Competent Authority portals, and solid working relationships with regulators, all to pre-empt potential obstacles that would ordinarily discourage them from seeking EU certification.”

Acorn Regulatory
www.acornregulatory.com

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech