Office Hours

Office Hours with Barry Sands, President and Founder of RQMIS Inc.,

Tuesday Feb 27th at the Life Sciences Research Institute (1344 Summer Street, Halifax)

Please REGISTER below for a specific time with Barry to discuss your health technology regulatory planning needs.

RQMIS President and Founder, Barry E. Sands, is a Biomedical Engineer, with a chemical engineering specialty, with a passion for helping medical companies get their products to market. Barry has seven years’ experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District. This government experience was followed with seventeen years in midlevel and executive management positions in small start-up and large multinational medical device companies. Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan, and South Korea.

Barry has provided companies with regulatory and clinical strategic advice on bringing novel technologies for both the pediatric and adult populations to the United States and EU markets. The devices involved have included in-vitro diagnostics, human tissue, surgical devices, combination products, drug delivery devices and detection, electromechanical, ultrasonic imaging and PACS products and wearable devices. He has authored protocols/investigational plans and maintained regulatory approval for 13 clinical studies focused on spinal surgery, including spinal disc replacement, spinal disc repair, spinal reconstruction, and bone/soft tissue repair/replacement. He has followed these clinical studies by writing PMAs/HDEs for these spinal implants.

Barry has managed FDA inspections and Notified Body Audits (TUV Rheinland, DEKRA, BSI, etc.) in R&D facilities (including clinical study files) and manufacturing facilities located in the United States, EU, and Japan. These FDA inspections have included Level 1 (Abbreviated), Level 2 (Comprehensive), Level 3 (Compliance Follow-up), For Cause, Sterilization processes, MDR/MedWatch, Corrections and Removals Practices, and Biomonitoring/Good Clinical Practices. ISO 13485 and MDSAP audits have included certification and surveillance audits. Barry has designed/implemented corrective actions to resolve 483s, Warning Letters, nonconformity reports and import detentions.

RQMIS Inc has a proven track record of integrating regulatory, clinical, and quality requirements with product lifecycle success. RQMIS has deep experience in developing comprehensive global regulatory strategy, with an intense focus on client needs, to produce results that meet only the highest quality standards.