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Services

Righter Consulting Group is the right choice for you if:

  • You are a developer of technology (including hardware & software solutions) that might be considered a medical device but do not know how to make that final judgment.

  • You are a medical device start-up that needs guidance on how to launch your regulatory and quality management strategy.

  • You are an established medical device company that needs a helping hand to guide you into unfamiliar territory.

 

RCG can guide you in the right direction with our a la carte consulting services.

Regulatory

Compliance is at the heart of our business. Below are some responsibilities we can take on:

  • Determination of product classification

 

  • Formal regulatory strategy and pathway

 

  • Registration and listing of your company and device

  • Development of design control documentation:

    • design development plan

    • user needs

    • design requirements

    • design output documentation

    • V&V plans/reports

    • risk management file

  • Analysis of acceptability for FDA and other regulatory bodies:

    • product classification

    • FDA product codes

    • indications for use

    • predicate device analysis

    • device description

    • etc.

Quality Management

Many companies do not initially address quality management because it is not seen as a value-added activity. This is understandable because companies need to be focused on getting products to market. This is where RCG can help. We can provide early quality and regulatory planning that has major benefits including more consistent operations, and limited findings of non-conformity during an audit.

 

RCG can provide guidance, write or assist with the design and implementation of a corporate Quality Management System for compliance with 21CFR Part 820 and/or ISO13485.

Other Services

Aside from those regulatory and and quality systems services listed, we can assist with other corporate goals upon request. We have extensive experience with medical device design and development, manufacturing, operations, and quality assurance.

 

Some example services:

  • Collaborative mechanical & electronics design

  • Collaborative software design & testing

  • Manufacturer selection & supplier audits

  • Manufacturing work instructions

  • Internal quality audits

  • Support for external audits

  • Remote and in-person quality system training

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