Medical Devices HR Challenges

HR Challenges Unique to Your Industry

  • !ISO 13485 and FDA QSR workforce training documentation requirements
  • !Recruiting and retaining specialized engineering and regulatory affairs talent
  • !Background checks for employees with access to proprietary device designs
  • !Complex exempt/non-exempt classifications for R&D and lab roles
  • !Multi-site compliance for device manufacturing, testing, and distribution
  • !Strict IP and non-compete agreements for design and engineering staff
  • !HR documentation standards required for FDA 21 CFR Part 820 audits
Catapult Solutions

How Catapult HR Helps

  • +ISO 13485-aligned HR training documentation and competency recordkeeping
  • +Recruitment and retention support for engineering and regulatory affairs roles
  • +Employment agreements with IP protection and non-compete provisions
  • +Wage and hour audits for R&D, lab, and production exempt classifications
  • +Employee handbooks with device-industry-specific policies
  • +HR compliance audit aligned with FDA QSR documentation requirements
  • +Multi-state HR compliance for distributed manufacturing and sales teams

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74%
Of medical device companies cite talent retention as their top HR challenge
$55K
Average cost of an HR documentation gap identified during an FDA audit
2.1x
Higher turnover cost for specialized device engineers vs. general manufacturing roles

HR Services for Medical Devices Employers

Expert support across the HR functions that matter most to your industry

Compliance

Background Screening

Pre-employment screening for design, lab, and manufacturing roles with access to proprietary device IP.

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“When our FDA auditor asked for training records, we had everything organized and ready. Catapult helped us build the HR infrastructure that makes audits stress-free.”

Quality & Compliance Manager, Medical Device Manufacturer — 150 employees, Research Triangle, NC

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HR Built for Medical Device Companies — Audit-Ready, Always

Our practitioners understand ISO 13485, FDA QSR, and the workforce documentation standards device manufacturers must meet.

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