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QUALITY SYSTEMS AND COMPLIANCE

Quality Systems and Compliance

ESTABLISH QUALITY SYSTEM AND PRODUCTS THAT BUILD YOUR COMPANY’S REPUTATION

Quality is everything when it comes to medical devices. Regulatory authorities require it, physicians expect it, and patients depend on it. Establishing comprehensive quality systems and quality products can help you build a reputation for integrity with your customers that will result in repeat business, which that can be a difficult task because of the proliferation of standards and quality system requirements worldwide.

Our skilled QA/RA staff understands the global quality and compliance requirements. Our staff has significant experience creating quality systems that comply with the U.S. Food and Drug Administration regulations as well as those of the European Union, Japan, Australia, and Canada with CMDCAS. We can ensure your product is designed to comply with ISO 13485 and applicable product safety standards. We can help you establish the quality systems and quality products you need to prevent deficiencies typically identified during quality audits or the problems that result in a product recall.

QUALITY AND COMPLIANCE CAPABILITIES INCLUDE:

  •     Selection and interpretation of US and international quality system requirements
  •     Drafting ISO 13485 quality manuals and procedures
  •     Conducting gap analyses, pre-audits, and internal audits
  •     Assessing applicable product safety standards and developing product safety test protocols
  •     Developing Medical Device Reporting (MDR) and European vigilance reporting systems
  •     Performing regulatory audits
  •     Preparing Technical Files and Design Dossiers
  •     Manage Quality Systems for virtual companies
  •     Communications for product field actions (safety alerts, product recalls, corrective actions)
Contact us at Fang when you are looking for a consultant, audit, and top regulatory firm to support your quality and compliance needs. We can outline a quality system audit that would be the most beneficial for your company, or we can give you general guidance for how to approach building and maintaining a compliant QMS.
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