Tailored Guidance for Industry Compliance
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Specialized Solutions
At Quality System Modelers, we're dedicated to ensuring your quality operations align seamlessly with U.S. and EU regulations and associated ISO standards, regardless of your manufacturing type. Our services are meticulously crafted to support:
- Medical Device Manufacturing
- Class I, II, IIa/IIb, III
- In Vitro Diagnostic Devices (IVD)
We're here to guide you through the complexities of compliance, ensuring your Quality Management System (QMS) not only meets, but exceeds industry standards.
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Virtual Services
QMS Project Management
Streamlined oversight for your QMS initiatives.
QMS Assistance / Guidance
Direct support from our experts to navigate your QMS landscape.
Customer Service
On-demand help for your immediate QMS questions.
Quality Audits
Comprehensive reviews of your existing Quality Management System to identify areas for improvement.
Candidate Evaluations
Pre-evaluating potential candidates for your first-hire of Quality and/or Regulatory associates.
On-site Services
Auditing Services
Conducted by our certified experts, these audits are designed to provide you with a clear, actionable plan based on the scope of work—tailored to your specific needs using auditing practices compliant with ISO 19011 standards. Our auditing services include:
First-Party Audits
Internal auditing services to evaluate your QMS to determine level of compliance or process improvement needs. Includes identification of nonconformances and recommended improvements.
Second-Party Audits
Assessments of your suppliers to ensure they meet your QMS and regulatory requirements.
Third-Party Mock Inspections
Preparation for official certifications or accreditations, offering insights and objectives for compliance. Not just your QMS preparedness, but your people preparedness as well.
QMS Project Management
Full support for QMS initiative implementations.
Partner Services
We offer free referrals to our fully-qualified, collaboration partners in the following areas of expertise:
REACH and RoHS
Assist with your REACH and RoHS implementation and training.
FDA Submissions
Assist with or perform your 510(k), PMA, NDA, etc. submissions.
ROW Compliance
Provide full-spectrum services for all compliance venues, if you choose to market your devices outside the United States.
Contact Us
Ready for a Conversation? Schedule a meeting with our team. Let's discuss your needs and find the best solutions for your Quality compliance challenges.