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Having the right consulting partner at the right time can be invaluable in attaining compliance and access to the medical devices and medical technology markets. RCG drives successful engagements by understanding the entire MedTech landscape. From design control to the FDA submissions process, we support clients through the complex and nuanced processes that medical device companies face to achieve market clearance.
We provide a wide range of medical device-specific, quality, and regulatory consulting services across the full spectrum of product design and development through post-market support. With our approach, you maintain project control while benefiting from external support from RCG. Whether your goals are to extend your in-house capabilities or obtain access to industry technical expertise, RCG can meet your every need.
Our Services
Our Services
Product Development Strategy
DMR / DHR Development & Gap Assessment
Design Control Development and Analysis
Process Validation
Clinical Research Development
Clinical Trial Development
Clinical Protocol Development
IRB Preparation
Product Discovery
Human Factors Testing Development
Quality Management System Implementation
Quality Management Gap Assessment
Risk Management Program
Internal Audits
Training Records and Job Descriptions
Corrective Action, Preventative Action, and Continual Improvement Program
ISO 13485 Preparation
Reimbursement Analysis
Medical Director Interviews
Code Analysis and Application
Reimbursement Due Diligence
Regulatory Pathway Analysis
Registration and Classification Assistance
FDA Communication (Q-Subs, Appeals, STeP)
FDA Submission Construction (510(k), Breakthrough,De Novo,IDE)
Health Economics Analysis
Medical Policy Research
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