Expertise

Medical Device Manufacturing Validation

Expertise

Medical Device Manufacturing Validation

Get your medical device or combination drug-device facility up and running quickly and keep it running efficiently with ongoing change control and validation maintenance services.

Never be left wondering where your project stands. Our custom client dashboard tracks every piece of documentation, provides detailed progress reports with Level 1–3 schedules, indicates current financials, and charts earned value curves — all the critical project details at your fingertips.

Build the Exact CQV Team You Need

When you need the right CQV experts on site to handle planned validation maintenance or surprise change controls, turn to our database of highly skilled, on-demand CQV professionals. Choose from experienced construction managers, project managers, C&Q technical leads, C&Q consultants, C&Q engineers, documentation specialists, and more.

Automatic robot in a smart factory assembly line

Get your medical device or combination drug-device facility up and running quickly and keep it running efficiently with ongoing change control and validation maintenance services.

Never be left wondering where your project stands. Our custom client dashboard tracks every piece of documentation, provides detailed progress reports with Level 1–3 schedules, indicates current financials, and charts earned value curves — all the critical project details at your fingertips.

Build the Exact CQV Team You Need

When you need the right CQV experts on site to handle planned validation maintenance or surprise change controls, turn to our database of highly skilled, on-demand CQV professionals. Choose from experienced construction managers, project managers, C&Q technical leads, C&Q consultants, C&Q engineers, documentation specialists, and more.

ICQ in Action

Getting a new facility back on track.

“In the end, the biologics manufacturing facility was commissioned and qualified with no issues noted during the FDA inspection.”

Kimberly Byrd
Former Associate Director for Validation
MannKind Corporation

Kimberly Byrd
Former Associate Director for Validation
MannKind Corporation

Medical Device Expertise

  • Commissioning and qualification program development
  • Comprehensive validation planning and execution
  • Quality procedure audits
  • Quality management system alignment
  • Strategic gap assessments
  • Operational and inspection readiness
  • Project controls
  • Facility start-up
  • Change management processes
  • GMP facilities
  • Medical device manufacturing facilities
  • Combination drug-device manufacturing facilities
  • CDMO facilities
  • Single-use facilities
Contact Your Local Rep

Contact Your Local Rep