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General Consulting

Lean Six Sigma for Regulated Companies

Increasing regulatory scrutiny and rigor, remote supply chains, and global competition are the new realities for medical device manufacturers. At a minimum, your company must produce high-quality devices and comply with tough regulatory requirements. To thrive, you company must continually improve its processes, cut waste, reduce costs and increase customer satisfaction.

Lean Six Sigma, a systematic approach to performance improvement that focuses on the customer, helps companies meet these challenges. Axeon merges Life Sciences regulatory information with Lean Six Sigma to eke out the essence of process control and regulation compliance.

 

Staff Augmentation / Outsourced RA/QA Support

Axeon’s staff augmentation and outsources RA/QA support program addresses fluctuating resource capability or capacity so you can manage FDA-related quality, regulatory, and/or compliance protocols.

Axeon highly experienced Medical Device Regulatory and Quality Assurance experts are available to supplement your organization efforts, address an immediate regulatory challenge or aid during periods of organization transition.

 

Our experts can help when you need to:

  • Prepare a global regulatory strategy, 510(k) or PMA submission, STED application, design dossier/technical file, and other product registration documentation for regulatory submission and worldwide product registration.
  • Obtain independent expert quality and/or regulatory guidance on project teams in commonly known problem areas within a Quality System, such as CAPA, Complaint Handling, Design Controls, and Supplier Quality – or when you require assistance with recalls.
  • Facilitate global regulatory compliance to applicable requirements and standards, such as ISO 13485, FDA GMP, and other quality system specifications.
  • Mitigate serious Quality System deficiencies, including development and implementation of corrective action plans to address 483 observations, warning letters, or consent decrees.
  • Ensure consistency, completeness, and adherence to standards for FDA submissions.
  • Establish and maintain relationships with regulatory agencies, including US, international, and selected registrars.
  • Conduct gap analysis and/or risk assessment and take actions to mitigate risks that have been identified.
  • Plan, design, and deliver training programs, including evaluating their effectiveness.
  • Audit your Quality Management System or a supplier’s Quality System.
  • Ensure that you’re prepared and ready for an FDA inspection or an audit.