651-347-4521 connect@waddellgrp.com LinkedIn
  • Home
  • About
  • Our Team
  • Services
    • Project Consulting: Product Development
    • Regulatory Project Management
    • Recall Management
    • Medical Device Manufacturing Sites
    • Process Engineering
    • M&A Integration
    • Recruiting
    • Project Initiation
    • Leadership Development
    • Interim Executive
  • Our Work
  • Blog
  • Jobs
  • Contact
  • Home
  • About
  • Our Team
  • Services
    • Project Consulting: Product Development
    • Regulatory Project Management
    • Recall Management
    • Medical Device Manufacturing Sites
    • Process Engineering
    • M&A Integration
    • Recruiting
    • Project Initiation
    • Leadership Development
    • Interim Executive
  • Our Work
  • Blog
  • Jobs
  • Contact
Home / 2017 / August

Monthly Archives: August 2017

World Map
29Aug

MDSAP – The Beginning of a 3 Year Debacle For Medical Device Companies

  • Rich Gall
  • Information

The Notified Bodies are already very busy and our medical device manufacturing clients are already seeing increased audit times. Several European Notified Bodies are no longer taking new clients with the onset of MDSAP (inclusive of ISO13485:2016), MEDDEV 2.7.1 Rev. 4 & MDR. This is the beginning of a 3-year debacle for medical device companies. These substantial regulatory reforms are now underway and will be required over the next 3-5 years: MDSAP will become the mandatory replacement for the CMDCAS certification to support Canadian device approvals on January 1, 2019…
Read More »

Navigation

  • Home
  • About
  • Our Team
  • Services
  • Our Work
  • Blog
  • Jobs
  • Contact

Contact Us

ADDRESS

Waddell Group
1191 Pike Lake Dr
New Brighton, MN 55112

INFORMATION

connect@waddellgrp.com
651-347-4521

BUSINESS HOURS

Monday – Friday: 8am to 5 pm

SOCIAL

LinkedIn

Find Us