At Realistic Quality Solutions (RQS), we provide end-to-end compliance, quality assurance, regulatory strategy, and cybersecurity consulting tailored to the evolving needs of medical device manufacturers.
Additional RQS Services – Strategic Resources for Industry Success, which include:
- Cybersecurity & Software Validation Compliance
- Manufacturing & Engineering Resource Access
- Risk Management & Compliance Strategies
- Marketing, Labeling & Regulatory Strategy Development
- Mergers & Acquisitions – Compliance Due Diligence & Post-Acquisition Intégration
- Reprocessing of Single-Use Medical Devices (SUDs)
- Product Development, Failure Investigation & Root Cause Analysis
- Business Development & Organizational Growth Strategies
- Clinical Research & Study Support
- Legal & Regulatory Counsel for FDA Compliance
- Providing post-market surveillance systems
- Unique Device Identification (UDI) labeling compliance
- Connecting clients with Clinical Research Organizations (CROs) and Clinical Research Associates (CRAs) as needed.
- Supporting design transfer, supplier qualification, and production validation
With Realistic Quality Solutions, companies gain industry-leading expertise, resources, and strategic compliance support, ensuring regulatory success, cybersecurity resilience, and operational excellence.
John Sawyer & Neil O’Flaherty will be part of an FDA WATCH Podcast discussing key issues affecting FDA and medical devices. John will be discussing Cybersecurity/AI and the new/upcoming Quality System Regulations.
Listen here or on PocketCasts, SoundCloud, Spotify, Google Podcasts, Apple Podcasts, and RSS.