Sequoia’s team of seasoned scientists, engineers, quality experts, and business professionals collaborate closely with our clients in the diagnostics and medical device sectors to support their evolving needs. Our team possesses extensive expertise in both diagnostics and medical device industry regulations and compliance standards, with demonstrated proficiency in developing chemistry, software, instrumentation, and other hardware devices.
Our Expertise
We understand the complexities our diagnostics clients face in navigating evolving regulations and guidance. Our commitment to their success is reflected in delivering customized, phase-appropriate solutions that precisely align with their intended use and regulatory compliance requirements.
Our team is dedicated to helping our clients streamline their product lifecycle and development processes, establish sustainable and scalable business operations, ensure product quality from development through validation, and optimize their manufacturing efficiency. By working together, our goal is to empower diagnostics and medical device organizations to bring innovative products to market faster and more efficiently, ensuring operational readiness for clinical trials, commercialization, and post-market surveillance.
Sequoia has expertise in navigating multiple U.S. and international requirements to assess, develop and ensure alignment to lifecycle standards, guidance, and regulatory compliant applications in the diagnostics and medical device sectors.
Relevant expertise, regulations, and guidance include but are not limited to:
- 21 CFR 820: Quality System Regulation
- 21 CFR Part 11: Electronic Records; Electronic Signatures
- ISO 13485: Quality Management Systems
- ISO 9001: Quality Management Systems
- ISO 27001: Information Security Standard
- ISO 17025: Testing and Calibration Laboratories
- ISO 14971: Risk Management
- ISO 13485: Quality Management Systems
- ISO 9001: Quality Management Systems
- Research Use Only (RUO)
- Laboratory Developed Tests (LDTs)
- In Vitro Diagnostics (IVDs)
- Medical Devices (Class I, II, III)
- EU In Vitro Diagnostics Medical Device Regulation (IVDR)
- MDR 2017/745: Medical Device Regulation (EU)
- Clinical Laboratory Improvement Amendments of 1988 (CLIA)
- College of American Pathologists (CAP)