Regulatory Compliance

Medical Device Consulting That Gets You To Market


Quality Management System


QMS Phase 1:  Initiation of formal development activity under QMS
* Signature Authority
* Document Control
* Change Control
* Design Control
* Risk Management
* Design review
 
QMS Phase 2:  Prepare for post-Design Inputs Development
* Software & Electronic Data Validation Procedure
* Training Procedure
* Supplier Qualification Procedure
* Statistical Technique Procedure
* Quality Planning Procedure
* Risk Management Plan
* Personnel Qualification Assurance Procedure
* Control of R&D measuring equipment Procedure
* Additional Design Control subsidiary forms


QMS Phase 3:  Prepare to produce product for verification and validation activities
* Product & Software Requirement Traceability
* Purchasing Procedure
* Material Control Procedure
* Production & Process Controls Procedure
* Process Validation & Verification Procedure
* Contract Review Procedure
* Equipment Maintenance & Inspection Procedure
* Control of Production Measuring Equipment Procedure
* Additional Design Control subsidiary forms
 
QMS Phase 4:  Prepare for design transfer and entry into the market
* Additional Design Control subsidiary forms
* Audit Procedure
* Customer Service Procedure
* Management Review Procedure
* Rework Procedure
* CAPA Procedure
* Labeling Procedure
* Nonconforming Procedure
* Product Distribution Procedure
* Facility Control Procedure
* Device Master Record, History Record, & Design History File
* Record Retention Procedure
* Complaint Procedure
* Medical Device Report & Vigilance Procedure
* Corrections & Removal Procedure
* Service & Installation Procedure
* First Article Inspection Procedure
* Post-market Surveillance Procedure

FDA regulations are complicated. But your design control process doesn’t need to be. We can help you take control of your medical device development and bring your product to market.

Medical design control stages from both the FDA and the ISO consist of:
  • Design & development planning.
  • Design inputs.
  • Design outputs.
  • Design review.
  • Design verification.
  • Design validation.
  • Design transfer.
  • Design changes.
  • Design history file.

FDA regulations are complex and lengthy.  We can assist you with the preparation of your Design Control quality management system, we can train your personnel or audit your subcontractors, and we can help you manage compliance with the Design Control regulation.  We also can assist you with the design, execution, analysis, and documentation of the required verifications and validation procedures, including software validations, for your specific type of medical device.  Additionally, we can provide you with the complete set of technical management consulting services necessary to better integrate your engineering functions with the rest of your business, improving productivity and performance.

We have been helped dozens and dozens of companies all over the world bring their products to market.

Find out how we can help you!