Quality Systems

Quality System Development

Boston Biomedical Associates understands that all businesses are unique, but require consistency, quality and repeatability, which are the key components to a successful medical product company. Whether you are a newly emerging company or an existing multinational corporation, BBA can help you ensure your quality system fits your organizational structure.

BBA’s philosophy for developing and implementing Quality Systems is to execute a staged approach to meet your needs based upon your current phase of product development.  Our leadership team will ensure that the systems we develop meet the regulatory requirements while not burdening you with overly cumbersome systems.

Our Quality Systems include all elements of the following:

  • US QS Regulation contained in the Code of Federal Regulations,
  • Requirements of ISO 13485 and/or ISO 9001, CMDCAS (Canada), and TGA (Australia).
  • Management and Organization Responsibility
  • Quality Manual Preparation
  • Personnel Training & Risk Management
  • Design and Document Controls
  • Purchasing and Vendor Controls
  • Identification and Traceability
  • Inspection and Calibration
  • Production and Process Controls
  • Nonconforming Materials
  • Packaging and Labeling Control
  • Development of Corrective and Preventive Actions (CAPA)
  • Handling, Storage, Distribution, and Installation
  • Process Validation
  • Sterilization
  • Product Release
  • Complaint Handling and Product Returns
  • Field Corrective Actions
  • Management Review

Quality System Implementation

  • SOP Implementation and Employee Training
  • Corrective and Preventive Actions (CAPA) Process
  • Quality System Audits
  • Quality System Maintenance
  • Notified Body Selection
  • ISO 13485 Certification

Quality Audits

As a medical product company, you are required to have valid and reliable information and processes.  We are capable of conducting effective gap analyses of existing quality systems and compliance throughout the product life cycle.  BBA staff can provide an assessment of your company’s internal Quality System controls as well as your clinical sites’ ability to accurately collect and document information pertinent to your trial. We also help you prepare for audits (FDA, Notified Body, or other Regulatory bodies) and conduct various types of internal and external auditing including:

Audit Services

  • ISO 13485/9001
  • Quality System Regulation (QSR)/Current Good Manufacturing Practices (cGMP)
  • Good Clinical Practices (GCP)
  • Good Tissue Practices (GTP)
  • BIMO preparatory and Investigative Site Audit
  • Vendor and Supplier Audits
  • Institutional Review Boards
  • GCP (Good Clinical Practice)
  • GLP (Good Laboratory Practice)
  • QSR (Quality System Regulations)
  • ISO 13485
  • EU Medical Device Directive
  • Medical Device Reporting (MDR)/Vigilance Reporting systems

Regulatory Inspection Preparedness

  • Conduct FDA and MHRA mock regulatory inspections
  • Provide training to prepare investigator sites for regulatory inspections
  • Assist preparing responses to inspection findings

System Validation Services

  • Computer systems
  • Databases

Validation and Audit of Study Related Documents

  • Protocols
  • CRFs
  • Clinical study reports
  • Study files
  • Tables and listings

To Discuss Your Quality System Needs with a Member of the Quality Systems Team

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