Quality Systems Consulting
A well-designed quality management system isn’t just a requirement – it’s a tool that works for you.
We specialize in right-sizing your QMS to meet your specific goals and operational realities.
We Offer
Full scope engagements
Project based engagements
Full scope engagements
We ensure your QMS is built or refined to fit your size and stage, avoiding the pitfalls of overly complex systems designed for larger companies.
Gap Assessment
If your QMS is non-existent or immature, then a gap assessment is the best first step.
OR
Internal Audit
If your QMS is complete, or close to it, then an internal audit is the best place to start.
Project based engagements
We can jump in to help targeted solutions for immediate needs. Examples of project-based engagements include:
CAPA closure and/or effectiveness checks
Audit preparation or remediation
Management reviews
Launch of a new product or process
Get to Work
Achieving Your Goals Within Your Constraints
We understand that medical device start-ups and small companies face unique challenges with limited resources and tight timelines. That’s why our ‘Get to Work’ process is designed to prioritize and plan next steps while always considering your available resources, timeline, and budget. Whether you need urgent support or a long-term plan, we provide the strategy and execution to help you reach your quality and compliance destination.
Frequently Asked Questions
What if I already have a quality system, but it’s not useful?
We see this all the time. The most common reason is that a previous consultant or employee dropped off a QMS that they used at a previous company. More often than not, that QMS was designed for a large mature company and isn’t suitable for a small or early-stage company.
How do you work with our team?
We have developed flexible approaches for different situations. If you have quality assurance personnel, we partner with them to implement the plan. If not, Qualomics can work independently. While we are capable of working autonomously, we strongly believe that involving your team leads to the best outcome. This collaboration helps build your internal expertise and ensures the quality system is fully integrated and sustainable.
Do you provide hands-on support?
Yes, absolutely. We are proud of what sets us apart. Unlike many competitors who may be former executives out of touch with daily realities, we provide direct, hands-on support. We work alongside you to tackle the day-to-day tasks of quality management, including document control, corrective action implementation, complaint handling, and all other aspects of ISO 13485 and 21 CFR 820 requirements. We always keep an eye on how our plans impact your operations.
Do you provide strategic support?
Absolutely. Our team includes expertise from executive down to associate level, enabling us to provide high-level strategic guidance, such as strategic planning for your quality system, in addition to hands-on execution.
How do you charge for consulting work?
We charge a transparent hourly rate for the work performed. You receive a monthly report detailing our time and tasks. Based on our experience, we do not accept fixed-price consulting projects. Quality system implementation involves many variables outside our direct control, making fixed pricing impractical and often leading to unexpected issues. Our hourly approach ensures flexibility and that you only pay for the support you need.