Regulatory & Clinical Strategy
Providing comprehensive and strategic regulatory/clinical pathways to achieve your goal of launching a medical device.
Our strategic planning is not simply focused on short-term results. Planning, implementing and managing a regulatory/clinical/quality/ insurance reimbursement strategy to gain and maintain marketing clearance and favorable insurance reimbursement are critical to a company’s success.
RQMIS strategic plans include consideration of:
- use of geographic markets with lowest regulatory hurdle while achieving business objectives
- preclinical and clinical study requirements during design control and for regulatory submissions
- risk management
- insurance reimbursement requirements while designing clinical studies
- assuring product labeling (including indications for use/intended use) and claims are written to optimize sales/marketing
- maintaining compliance with all relevant medical device regulations
- negotiating with government bodies (FDA, CMS and Competent Authorities) to enhance the company's success with regulatory submissions (510(k), IDE, PMA, Design Dossiers, Canadian Licenses, etc.) and insurance reimbursement.
- quality system advice focused on the practical aspects of product development and manufacturing. Quality Systems are designed and evaluated not only for compliance but also for their level of effectiveness in providing a medical device that customers need and can reliably use.
RQMIS can provide both comprehensive service that addresses all aspects of achieving regulatory marketing clearance and insurance reimbursement of your products or we can provide focused advice on specific issues or concerns.
Comprehensive service will provide your company a road map of all of the issues you need to address to achieve/maintain marketing clearance and insurance reimbursement. RQMIS, as a partner with your company, will then execute this plan to assure effective implementation. In a more focused role, RQMIS can provide support in writing individual marketing submissions, advise/draft responses to regulatory bodies, perform health hazard evaluations, etc. RQMIS is very adaptable to your current needs.
The need to develop a regulatory strategy to achieve your goal of launching a medical device will directly impact both timing and cost of product development. Understanding the difference in the regulatory requirements in each geographical market allows you to take advantage of lower costs of entry to begin the generation of revenue and further development of clinical evidence of product use. This earlier entry allows your organization to better understand the real world application of your technology to further refine the product design, improve manufacturing processes and enhance customer support.
RQMIS consultants have provided strategic regulatory advice that has allowed both small and large companies to take advantage of geographic markets with lower regulatory cost of entry. These clients have realized significant advantages in enhancing both the product design and customer acceptance while accelerating product development timelines in markets with higher regulatory costs of entry.
Clinical Studies Strategy
When your medical product is new to the clinical environment regulatory bodies and competent authorities may require clinical evidence to support regulatory clearance. In addition, during product development a need to develop clinical evidence to support design validation and insurance reimbursement may occur.
RQMIS has a long history of understanding/negotiating clinical data requirements required by FDA, Competent Authorities and CMS. We have a thorough knowledge of how to implement clinical studies that comply with FDA and international clinical study standards (EN/ISO 14155). RQMIS consultants have custom designed and implemented clinical study plans to develop clinical evidence in the EU, South America and the Middle East which supported the initiation of phase III studies in the United States. These strategies have allowed companies to reduce product development timelines by one year or more, obtain CE mark sooner and reach phase III US studies faster than their competitors.