PAUL NEEDLER

Managing Director + QMS Specialist

Paul began his career as a technical support and service management professional building support plans for design firms and building up customer support centres with level 1 and 2 support tiers.  

In 2010, Paul shifted gears and entered the Regulatory Affairs space and developed his skills in Quality Assurance, Regulatory Strategy and Quality Systems Management.  Since 2017, Paul has specialized in ISO 9001 and ISO 13485 Quality Systems and local regulations in the US (21 CFR 820) and Canada (CMDR).

Paul has also ventured into the EcoManagement space and honed his entrepreneurial and product design skills by developing, marketing, and manufacturing an innovative rain catchment system for homes, all within a strictly regulated environment.  

EXPERTISE, MISSION & VISION

  • 15+ years experience in Regulatory and Quality Systems
  • Well-developed skills across many industries
  • Takes the time to learn your business
  • Believes in the “Work With” approach
  • Extreme attention to detail
  • Experienced trainer

RECENT CASE STUDIES

Biosign Technologies Inc.:

  • Product: UFIT, Medical Device, Wrist-cuff blood pressure monitor
  • Well-developed ISO 13485 QMS allowed for minimal investment in testing for the FDA 510(k) market submission that was cleared in a record-setting 97 days.

Cloud DX Inc:

  • Product: Pulsewave, Medical Device, Wrist-cuff blood pressure monitor
  • Well-developed ISO 13485 QMS and Risk Management enabled a low-investment, fast-to-market time on the next-generation product, the PAD-1A because the proven development process in the QMS was easily duplicated.  Thus the product was cleared and introduced to market promptly which suited all stakeholders.

PatientRM:

  • Product: Patient relationship management call centre for clinical trial sponsors
  • Built and implemented a Quality System and Privacy Management process that yielded an audit of 100% compliance when PatientRM was audited onsite in New Brunswick, Canada by a prospective client for 21 CFR 11 and FDA GDPR for privacy and electronic records handling.  The contract was won quite quickly and without challenge due to the audit’s success.

Cortex Design Inc:

  • Product: Industrial design services, medical device development and prototyping
  • Built, trained and implemented an ISO 9001 QMS.  This enabled a smooth and low-cost upgrade to ISO 13485 within 2 years.  The current certification year 2023 passed without any Corrective Actions.  This certification attracted new medical device businesses by a factor of over 4.

It’s never too early to consider a Quality Management System.
NeedlerQMS will show you how.