NAMSA offers comprehensive support to medical device companies in the areas of FDA quality system regulation (QSR) and ISO compliance for medical device companies.

Design Controls

We develop and implement design controls for manufacturers of medical devices, including IVDs (in vitro diagnostics), biologics, and combination products under ISO 9001/ISO 13485 and FDA’s quality system regulation (QSR).

Our consultants have worked with Fortune 100 through start-up manufacturers, assisting with establishment of design controls through conducting audits and “rescue” efforts. We scale the quality system effort to the needs of the company, its products, and its culture.

How NAMSA Can Help

  • Design control procedures and implementation
  • Design control audits
  • Design development plan
  • Design control project management
  • DMR (device master record)
  • Risk management program development and implementation per ISO 14971:2007
  • Risk Management Plans and Reports
  • Risk analysis
  • Failure modes and effects analysis (FMEA)
  • Fault tree analysis (FTA)
  • Preliminary hazard analysis (PHA)
  • Health hazard evaluation (HHE)
  • Medical Device product design history file compliance
  • Biocompatibility and sterilization assessment
  • Medical device standards assessment
  • Process validation (IQ/OQ/PQ)
  • Change control

Quality Systems

NAMSA develops and implements quality system and compliance strategies for manufacturers of medical devices including IVDs (in vitro diagnostics), biologics, and combination products. We assist clients in a variety of ways including quality system implementation, pre- and post-market compliance activities, risk management, and medical device product design control support.

How NAMSA Can Help

  • Advisory and consultative support (hourly)
  • Full system implementation
  • Audits
  • On-site staffing
  • Functioning as a virtual department
  • Emergency response
  • FDA interactions

We commonly help large medical device manufacturers with tasks such as these:

  • Improve or correct non-compliant quality system procedures, improving efficiency and compliance with corrective and preventive actions, complaint handling, device tracking
  • Support product recall efforts
  • Manage consistency of and optimize SOPs across business units
  • Correct non-compliances such as FDA 483 observations and warning letters
  • Perform internal audits
  • Perform supplier audits
  • Assist with process improvements
  • Perform risk assessments

NAMSA commonly helps startups and small manufacturers in these ways:

  • Function as an outsourced quality systems department
  • Implement total quality management systems compliant with the requirements of FDA 21 CFR Part 820, and ISO 13485
  • Perform supplier audits

We also perform a wide range of other tasks in the QS area:

  • Gap analyses and pre-certification assessments
  • Comprehensive quality system development and implementation
  • Document control procedures and implementation, including paper-based and software-driven quality systems
  • Work instruction development and process flow diagrams
  • Device master records (DMR) and device history records (DHR)
  • Customized training
  • Mock FDA and QSIT inspections
  • Part 11 compliance (electronic records and electronic signatures)
  • Quality records
  • Corrective and preventive action (CAPA) procedures and implementation, including root cause analysis
  • Complaint handling procedures and implementation
  • Medical device reporting (MDR) and vigilance reports
  • Assistance with medical device recalls
  • Enforcement action resolution
  • Development and facilitation of management review programs

Supplier Audits

NAMSA assists with supplier control through the preparation and audit of supplier quality systems. Supplier audits are used to evaluate suppliers, contractors, and consultants.

Our consultants are qualified to audit the following regulations and standards common to the industry:

  • FDA 21 CFR Part 820 Quality System Regulation (QSR)
  • ISO 13485:2003
  • ISO 9001:2000

Recent Audit Experience

  • Contract manufacturer – finished device
  • Contract sterilization service provider
  • Component supplier
  • Test lab
  • Outsourced manufacturing processes (packaging, sub-assembly, coating, laser welding)
  • Consultant services (clinical trial support, document control service provider)