Quality Systems Compliance Partners LLC

WHO WE ARE
Quality Systems Compliance Partners (QSCP) LLC is a medical device consulting firm dedicated to helping other companies:
-bring new devices to market or bring existing devices to new markets
-improve product quality or safety
-design, test, verify, and validate new products
-qualify new processes, new equipment, and new suppliers
-investigate and correct part, process, or product defects
-improve/remediate quality system issues

CAPABILITIES
As noted above, QSCP LLC has deep technical, quality, and regulatory experience to bring your project to a successful conclusion. We offer the following:

DO
Performing tasks and operations where there is a personnel/skills gap in the organization until that gap can be closed. You can rest assured knowing that these tasks are performed competently, compliantly, and completely.
Examples:
-Complaint intake, risk assessment, reportability decision, and investigation.
-Failure investigation, CAPA plan and execution
-Installation, operational, and performance qualification (IQ/OQ/PQ) plan and report
-510K or CE Mark submission

LEAD
We can lead your next quality or regulatory project using project management skills and a practical, collaborative approach to ensure your business meets its objectives. QSCP LLC can provide simple, sustainable strategies to minimize immediate and long-term impacts while delivering enhanced safety, compliance, and/or quality.
Examples:
-Global go-to-market strategy, planning, and timing.
-Create and perform supplier qualification and supplier audits

GUIDE
Where there are quality system gaps or issues, we can fill those with procedures, processes, and personnel training to remediate those gaps. In addition, we can create and perform competency assessments so that you and your organization KNOW you are meeting your objectives.
-Develop risk-based quality system: design and development; purchasing controls
-Create, lead, and monitor regulatory transition program to the EU MDR

Company’s Keywords:

complaint handling, purchasing controls, useability, medical device, risk management, iso 13485, supplier development, supplier qualification, iqoqpq, iec standards, verificationvalidation, mdr, capa, postmarket surveillance, design requirements, iso 14971, design controls, new product development, fda, change control