Medical Device Design Consulting

Medical Device Development
Quality Management - Regulatory Affairs - Product Development

Comprehensive Medical Device Development Approaches

QA/RA Consulting Group makes sure you have considered all relevant and applicable standards that apply to your product while expediting the documentation of the formal design/development process.

 

Your technical files/Design dossiers, Design History Files-(DHFs); etc. will be created in an indexed and easy to audit manner facilitating product approval and easing the transition for future design modifications that may be needed.

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Our medical device consultants specialize in Mechanical only devices, Electro-Mechanical devices, disposables sterile or non-sterile-(FDA Class I, II and III),  Combination Products (Devices / Drugs / Biologics), In-Vitro Diagnostics, along with special consideration for Human Factors/Usability aspects of these devices.

Services Include Support In:

New and existing product development per applicable quality systems with concurrent risk management (ISO14971)

  1. Market review and user needs assessment    

  2. Design Planning/ Standards test requirements

    • Program leadership

  3. Design Input/Development/Output strategy

    • Material Type Testing/compatibility

    • Biocompatibility (ISO10993) 

  4. Sterilization / Cleaning Process Strategy and Validation

    • Protocol/Report Development

  5. Verification and validation protocol and report development

  6. Materials compliance (i.e. RoHS)

  7. Usability/Human Factors

    • Usability Program Development 

    • Usability Product Design Audit

    • Formative and Summative Testing

    • Usability Study Design

    • BS EN 62366:2008 and ANSI/AAMI HE75:2009

    • Recruitment and User Screening

  8. Continuous traceability of requirements from top to bottom

Example of studies we've performed include:

  1. Enteral Feeding Disposables

  2. Enteral Feeding Pumps

  3. Heart Bypass 

  4. Angioplasty Catheters

  5. Introducers and Guide wires

  6. Sterile Disposable Tubing Sets

  7. IV Infusion Pumps

  8. Contrast Injection

  9. Pharmaceutical Mixing

  10. User Interfaces

  11. Deep Brain Injection

  12. Labeling and Instructions

Help From Start to Finish

To achieve milestones effectively, you need medical device consulting services at several checkpoints along the process. By hiring us you’ll save precious time and money along the way.