fbpx
(603) 448-2367 info@simbex.com Medical Device and Consumer Health Product Design and Development
  • Engineering
    • Mechanical & Electrical Design/Engineering
    • Design & Human Factors
    • Software & Web Development
    • Transfer to Manufacturing
    • Applied Research
    • Quality
  • Commercialization
    • Clinical Verification, Regulatory, & Reimbursement Strategy
    • Competitive Landscape
    • Technology: Planning, Protecting, & Documenting
  • Expertise
    • Case Studies
    • Why Simbex?
    • Wearables
    • Commercialization Centers
    • Technology Transfer Offices
  • About
    • Our Story
    • Leadership Team
    • Our Team
    • Our Network
    • Culture
    • Careers
  • News & Blog
  • Connect
Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace Bring new technology from ideation to the marketplace
  • Engineering
    • Mechanical & Electrical Design/Engineering
    • Design & Human Factors
    • Software & Web Development
    • Transfer to Manufacturing
    • Applied Research
    • Quality
  • Commercialization
    • Clinical Verification, Regulatory, & Reimbursement Strategy
    • Competitive Landscape
    • Technology: Planning, Protecting, & Documenting
  • Expertise
    • Case Studies
    • Why Simbex?
    • Wearables
    • Commercialization Centers
    • Technology Transfer Offices
  • About
    • Our Story
    • Leadership Team
    • Our Team
    • Our Network
    • Culture
    • Careers
  • News & Blog
  • Connect

News

 Medtech groups want more time to implement FDA’s QMSR rule and Public Health Emergency expected to be extended through the Fall

Medtech groups want more time to implement FDA’s QMSR rule and Public Health Emergency expected to be extended through the Fall

June 22, 2022

Regulatory Medtech groups want more time to implement FDA’s QMSR rule While the medtech industry is overwhelmingly supportive of the long-awaited proposed Quality Management System Regulation [...]

Read More
 FDA Expands eSTAR Filing To De Novo Devices, IVDs

FDA Expands eSTAR Filing To De Novo Devices, IVDs

January 11, 2022

Regulatory  FDA expands eSTAR filing to de novo devices, IVDs US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to [...]

Read More
 FDA Issues Draft Guidance For Device Software In Premarket Submissions

FDA Issues Draft Guidance For Device Software In Premarket Submissions

December 3, 2021

Regulatory FDA issues draft guidance for device software in premarket submissions The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about [...]

Read More
 CDRH outlines guidance plans for FY2022

CDRH outlines guidance plans for FY2022

November 1, 2021

Regulatory FDA nixes GUDID submission requirements for class I consumer healthcare devices Manufacturers of class I medical devices considered to be consumer healthcare products will get a [...]

Read More
 FDA Issues Draft Guidance On Electronic 510(k) Submissions and CMS Proposes to Repeal MCIT

FDA Issues Draft Guidance On Electronic 510(k) Submissions and CMS Proposes to Repeal MCIT

October 11, 2021

Regulatory FDA issues draft guidance on electronic 510(k) submissions The US Food and Drug Administration (FDA) issued a draft guidance to assist sponsors in using an electronic template for [...]

Read More
 Salona Global Medical Device Corp. Announces Acquisition of Simbex, a Multi-Product, IP-Driven Medical Device Company

Salona Global Medical Device Corp. Announces Acquisition of Simbex, a Multi-Product, IP-Driven Medical Device Company

October 4, 2021
Read More
 FDA Seeks Increased Oversight of Medical Device Cybersecurity and New HCPCS Codes Issued for Medical Devices

FDA Seeks Increased Oversight of Medical Device Cybersecurity and New HCPCS Codes Issued for Medical Devices

September 13, 2021

Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional legislative authorities” meant to bolster medical device cybersecurity amid [...]

Read More
 Medical Device Recalls Up in First Half of 2021 and Draft Cures 2.0 Bill Seeks Breakthrough Coverage

Medical Device Recalls Up in First Half of 2021 and Draft Cures 2.0 Bill Seeks Breakthrough Coverage

July 1, 2021
Read More
 The Art of Propelling Forward!

The Art of Propelling Forward!

June 21, 2021
Read More
 Simbex Designs Bioentrepreneurship Educational Series for Dartmouth Innovations Accelerator for Cancer

Simbex Designs Bioentrepreneurship Educational Series for Dartmouth Innovations Accelerator for Cancer

May 21, 2021
Read More
1 2 3 4 5 6 7 8
page 1 of 8
Simbex

Simbex is an experienced medical device and consumer health product design and development partner that excels in transforming your most complex ideas into game-changing commercial solutions.

About
  • Our Story
  • Culture
  • Careers
  • Our Work
Information
  • Engineering Services
  • Commercialization Services
  • News & Blog
  • Connect
Contact

10 Water St, Suite 410
Lebanon, NH 03766
(603) 448 2367
info@simbex.com

© 2022 Simbex. All Rights Reserved. Legal Notice | Privacy Policy | PatentsWebsite by RYCO

Start typing and press Enter to search