Services

Bob Duffy Associates (BDA) provides a range of services to help your company overcome hurdles in developing, introducing and maintaining successful products. We focus in three primary areas:

Design Manufacturing Regulatory & Standards Compliance

Nearly all the projects we do involve two or more of these areas.

Design

BDA provides design support services to help your company overcome hurdles in developing and introducing your products. Some of the key areas other Customers have found valuable are:

• Design planning and project management.
• Requirements and Specifications documentation and refinement.
• Documentation support for System, Electronics, Mechanical, Software and Biochemical/Microbiological design output.
• Design Verification and Validation including protocol writing, test execution and verification reports.
• Risk Management including planning, Risk Analysis and post-production aspects.
• Tracing between Risk Analysis, Requirements and Specifications, Design output and Design Verification and Validation.
• Organization and documentation for Design History Files, Technical Files, Design Dossiers and design support for 510(k) submission, CE Mark and other submissions.
• Planning and execution of Standards Compliance including IEC 60601-x, ISO 14971, IEC 62304, IEC 62366, ISO 10993-x and numerous others.
• Design Transfer to manufacturing.

Manufacturing

BDA provides manufacturing support services to help your company overcome hurdles in manufacturing your products throughout the product lifecycle. Some of the key areas other Customers have found valuable are:

• Transferring products into production.
• Creating, Release and maintenance of Device Master Records.
• Root-cause analysis and resolution of manufacturing issues including non-conforming material, supplier issues, and manufacturing yield issues.
• Obsolete component replacement.
• Test Equipment specification, design documentation and equipment validation including IQ, OQ and PQ.
• Process Validation including protocol writing, test execution and Process Validation reports.

Regulatory & Standards Compliance

BDA provides Regulatory and Standards compliance support services to help your company overcome hurdles in getting your products available for sale. Some of the key areas other Customers have found valuable are:

• Quality Management Systems including planning, developing, implementing, improving, certification and registration
• Standards Compliance including planning, execution and documentation of conformance with IEC 60601-x, ISO 14971, IEC 62304, IEC 62366, ISO 10993-x and numerous others.
• Regulatory submissions including 510(k), IDE and CE Mark
• Resolution of Regulatory issues including ISO audit findings, FDA 483’s and other Regulatory situations
• FDA Establishment Registration.