Regulatory and Quality Solutions LLC (R&Q) provides regulatory and quality consulting and engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients and seeks to enhance the commercialization and post-market processes for medical devices.
- R&Q can support your transition from ISO 13485:2003 to ISO 13485:2016 with strategic planning to hands-on support. Its services deliver business-balanced solutions that include: gap assessments, internal/mock audits, QMS processes and QMS training. Get more details in the ISO 13485:2016 fact sheet.
- R&Q can guide your transition to the EU MDR. From strategic planning to hands-on support, R&Q can help deliver business-balanced solutions that include: MDR impact assessments, MDR quality system gap assessments, design document gap assessments, gap response plans, clinical evaluation reports, mock EU MDR audits, notified body submission/AI response, post-market surveillance services and training. Get more details in the EU MDR transition fact sheet.
- R&Q can help you meet the requirements of MEDDEV 2.7.1 Rev 4 with strategic planning and hands-on support. R&Q’s services include: CER assessments, clinical evaluation plan strategies, clinical evaluation plans, clinical evaluation reports and clinical literature reviews. Get more details in the MEDDEV 2.7.1 fact sheet.
Visit Regulatory and Quality Solutions at booth #101 at DeviceTalks Boston.