Biomedical Quality Systems

Business Performance Associates has extensive experience in establishing biomedical quality systems.

We can help you comply with the following regulations/standards:

• ISO 9001:2000 (see ISO 9001 information on this web site)
• Quality System Regulation (for medical devices)
• ISO 13485:1996 or ISO 13485:2003
• 21 CFR Part 11
• Medical Device Directives (CE Marking for the European Community)
• Current Good Manufacturing Practice for the Manufacture,
  Processing, Packaging, or Holding of Drugs
• In Vitro Diagnostics Directive
• Guidelines on General Principles of Process Validation
• Good Laboratory Practice for Non-clinical Laboratory Studies
• Supplier Guide for Validation of Automated Systems in Pharmaceutical
• Manufacture, Good Manufacturing Practice (GAMP) Forum

Services

Assistance in complying with FDA and ISO requirements:

• Project management
• Conducting an audit/gap analysis
• Developing a plan for becoming compliant
• Assisting in the design of required systems, such a design control, process validation, contract review, purchasing, management responsibility, preparation of a quality manual, etc.
• Supporting preparation of documentation, or writing needed documentation for you
• Quality system training
• Training internal auditors
• For a more extensive list, see ISO 9001 Implementation

Compliance Support in meeting the European Community Directives for medical devices and in vitro diagnostic devices includes:

• Classifying your device
• Selecting a conformity route
• Assessing which essential requirements apply
• Consulting in meeting the essential requirements
• Preparing a technical file
• Selecting a European representative
• Selecting a notified body
• Preparing for a notified body audit
• Self declaring

Support in validation includes the validation of:

• Facilities and utilities
• Equipment
• Environmental chambers
• Computer Systems
• Software
• Processes

Our computer system validation and Part 11 services extend to applications, networks, information technology infrastructure, hardware and software. See software validation.

Training

• "Basic Quality Requirements for the Biomedical Industry"
• "New GMPs for the Medical Device Industry"
• "CE Marking for Medical Devices"
• "Closing Compliance Gaps in Medical Devices: New GMPs and CE Marking"

See Training Workshops for a complete list of workshops available from BPA

Benefits of our services

BPA provides the support you need to achieve your goals:

• Meet state, FDA and/or the European Community requirements
• Qualify to fix the CE Marking to your products
• Establish quality systems which ensure that your products perform as intended and are safe for your users

BPA's approach ensures the efficient and effective management of change, and enables you to:

• Comply with requirements quickly and efficiently
• Minimize costs by leveraging your resources

Contact Us
Call Tim Stein at 408-366-0848