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Medical Device Quality System Development

Quality Management Systems

quality system development iconA well thought out and implemented Quality Management System (QMS) provides the overarching structure for operating your medical device business in an efficient and compliant way.

QA Consulting has worked with approximately 50 medical device manufacturers to write and implement Standard Operating Procedures (SOPs) for their quality management systems.

We take great pride in that each of these companies has successfully completed FDA inspections and notified body audits without the issuance of a single Warning Letter or Major Nonconformance.

two med device consultants

Development of Standard Operation Procedures (SOPs)

The foundation of a successful Quality Management System is a series of thoughtfully developed SOPs that set the stage for how a company should operate.

For medical device manufacturers just starting out who lack the expertise and experience to write company SOPs, their options are typically to work with consultants like ours to generate customized procedures, or to purchase a suite of off-the-shelf templated documents.

The issue with the latter option is that the templates have often been developed with larger companies in mind and are too complex for a startup organization to follow.

Creating a QMS that is intentionally tailored to your company’s needs will save time and money in the long run.

Our project managers will approach your SOP generation by dividing the SOPs across multiple phases in an order that best fits your company’s development process.

With each phase, they will:

  • Conduct an up-front phase consultation
    To kick off each phase of SOPs, your project manager will meet with you to introduce the planned procedures, brief you on their general requirements, and discuss how your company will be able to fulfill those requirements.
  • Author your SOPs
    The project manager will use the feedback learned from the phase consultation to begin authoring your procedures, adapting and incorporating best practices as well as your company’s unique requirements into the regulatory requirements for each SOP.
  • Train on implementation
    Once all SOPs in a phase have your approval, your project manager will collaborate with you in a session dedicated to training on the SOPs and discussing best practices for implementation.

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