Welcome to Q-Metrics
Why choose Q-Metrics for your quality and regulatory consulting needs?
We specialize in supporting small-scale and emerging, more budget-conscious organizations - we will tailor our services to meet your needs
We pride ourselves on delivering on-time and on-budget
We are able to offer most of our services working remotely, saving travel expenses that normally make up a significant portion of consulting costs
If we don’t have what you need, we know someone who does - our vast network of industry specialists enable us to offer a wide variety of services, including sourcing, logistics, design, packaging - you name it
We are here when you need us - morning, noon and night, 24/7
Use the form below to contact us with your questions or to set up a no-charge consultation.
Medical Devices, OTC Drugs, Dietary Supplements
and Cosmetics
Regulatory
The world of regulatory is ever evolving. Staying on top of the changes, and anticipating and planning for future changes, is critical to the success of your organization. Q-Metrics is here to help you navigate the dynamic regulatory landscape.
Regulatory strategies
Regulatory submissions, including 510(k), 513(g), De Novo
Labeling reviews to ensure compliance
Unique Device Identifier (UDI)
Development of successful responses to regulatory inspection findings (FDA 483s, Warning Letters) and Customer/Third-Party audit findings
training
FDA Quality/Regulatory Training
FDA Preparedness Training
Annual Employee GMP Training
product quality
Product quality not only affects your ability to remain compliant with regulatory agencies, but also allows you to help ensure patient safety and maximize profits. Meeting customer requirements is also key. Q-Metrics can help set you up for success.
Quality control for your contract manufacturers
Inspection plans and product testing
Internal CAPAs for continuous improvement
Supplier CAPAs
internal and vendor audits
Onsite and Remote based auditing for:
Meeting regulatory/quality standard requirements
Preparation for regulatory inspections/third-party audits
Continuous improvement initiatives
quality systems
Designed to efficiently and effectively address the requirements of regulatory and third-party certifying bodies. Assistance with training and implementation is also available.
ISO13485 Medical Devices
21 CFR 820 Medical Devices
21 CFR 111 Dietary Supplements
Cosmetic Good Manufacturing Practices
EU, Health Canada and ROW compliant procedures
supplier management
Managing supplier relationships
Supplier site audits
Pre-shipment inspection of products
“ Begin with the end in mind.”
Let's Chat.
Q-Metrics knows that finding the right consultant is a choice not to be taken lightly. That’s why we offer free consultations to review your needs, the scope of your goals and your budget.
Use the form below to tell us about your quality or regulatory needs, and we’ll call you back to schedule an appointment. Please be as detailed as possible. Include what industry you need service for along with any specific projects/requirements you need support for. To help us best serve your inquiry, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email or call us to make an appointment. Our general response time is less than one business day. If your needs are more urgent, please feel free to reach out to us by phone!