Quality Management

Are you a pre-clinical medical device company building your quality management system and the product at the same time? You are not alone. We can help you build your QMS at the right pace as your product moves towards regulatory submission milestones and clinical use.  

Depending on your regulatory strategy, you may be exempt from some of the regulations under 21 CFR Part 820 (not 820.30!), but that doesn’t mean we can’t plan ahead. The best quality systems are tailored to your company’s needs and are ready for growth, so you can achieve a fast-paced scale up when the timing is right.  

We’ve built, repaired, and maintained quality management systems for both start-ups and established companies. We can help develop the right QMS for you.

QMS Implementation

Starting with an implementation plan, we determine your specific requirements and develop an appropriate roadmap. We focus on cost-effective solutions within a scope that grows as your needs do, and can support the development and implementation of your QMS from the first draft of the quality manual through your ISO 13485 compliance assessment and beyond, including requirements that may be dictated by your target regulatory markets.

For systems already established, we typically review processes with your team and recommend revisions that can help reduce the burden and increase the safety and efficiency of the system which can be performed within the scope of a formal audit.

QMS Rescue

Full or partial plant shut-downs, major personnel reductions, and other hiatuses from normal operation can be unfortunate realities -- complicated even further when there is limited time to prepare. In the post-COVID world with supply shortages and changes to worker mobility, these problems are all too common, and getting your system back up and running can be a major challenge. 

We can help you build and implement a step-by-step strategy to get back on track.

Typically, the process follows these fundamental steps: 

  • First, we establish the ability to maintain your core quality processes to ensure you continue to meet your regulatory obligations and maintain the safety of your users.  

  • Second, we quarantine all items and equipment for compliance and to assess status and determine the appropriate disposition. 

  • Then, we can begin rebuilding your system to align with your short- and long-term goals. Often this involves requalifying equipment, re-inspecting product, and similar quality checkpoints. We may even recommend decommissioning some equipment for the time being so you can focus on your core business. 

Whatever your situation, we can optimize the right recovery plan to get you back on track, with direct implementation support throughout the process.

Audit Support

Your product development journey and regulatory pathway can be fortified with the right audit support at key junctures. Success in these critical milestones set the stage for sustainable QMS compliance for years to come translating to consistent product quality. We support these tasks by taking both advisory and participatory roles in the following areas of successful leadership experience:

  • Internal audit planning and support

  • Second-arty/external auditing

  • Notified Body audit support