BeyondCompliance Information

The aim of Beyond Compliance, LLC is to help Life Sciences/Med Tech companies meet and exceed customer, regulator, and other stakeholder needs through better design and use of Quality Management Systems. We focus on organizations with a presence in the Northeastern United States (with particular emphasis on Massachusetts and greater New England) who design, manufacture, or provide services related to: Laboratory Developed Tests (LDTs), Companion Diagnostics, Medical Devices (including IVDs, Device Combination Products, and SaMD), or Quality Management software solutions. We are QMS experts and we are local, accessible, and highly focused. Our solutions are dynamic just like the needs of our clients. Beyond Compliance, LLC provides specialized professional consulting services to medical device and life science manufacturers, clinical laboratories, and quality system software manufacturers, as well as key suppliers of such organizations, with particular focus on (but not limited to) the following: ‣ Building or improving Quality Management Systems (in their entirety or targeted to specific areas of need): design, development, implementation, post-M&A integration, inspection-readiness, turnaround (transformation), and/or remediation. ‣ Helping Clinical Laboratories, designers and manufacturers of Personalized Medicines, and other organizations that design and/or produce laboratory developed tests (LDTs) prepare for and comply with the FDA LDT Framework (and other present and future global requirements). ‣ Partnering with organizations to help ensure successful adoption of Quality Management Software (QIS/e-QMS) solutions and sustained compliance and satisfaction. We also offer interim QA/RA leadership during organizational transitions. Visit us at www.Beyond-Compliance.com or www.LDTCompliance.com Follow us here on LinkedIn at BeyondCompliance and on Twitter at @beyondcompllc Contact us at: info@beyond-compliance.com (774)701-1952