NWRS Personalized Services
Our Services
NWRS’ provides individually customized services for start-up companies up to large Fortune 100 corporations.
We work with manufacturers and laboratories developing SARS-CoV-2 diagnostic products as regulatory consultants under the NIH-funded initiative, Rapid Acceleration of Diagnostic Products (RADx).
We specialize in point-of-care in vitro diagnostic devices, and our staff has backgrounds in R&D, human factors, quality systems, laboratory technology and clinical trials to assist with all phases of product realization, quality assurance and post-market surveillance.
Our areas of expertise include:
- Clinical, Non-Clinical and Flex Study Protocol development
- Emergency Use Authorization (EUA and pre-EUA) Submissions
- Pre-Submissions (Q-subs)
- Investigational Device Exemptions (IDE)
- 510(k) and De Novo submissions
- Premarket applications (PMA)
- CLIA Waiver Applications
- Dual 510(k)-CLIA Waiver submissions
- Breakthrough Devices Program (EAP) requests
- Quality System management for GMP compliance, CE marking and ISO certification
- Risk Management
- Human Factors
- Labeling and advertising
- Complaint Handling
- Post-Marketing Surveillance
- Recalls, vigilance and adverse event reporting
- Resolution and Remediation of Warning Letters and Non-Conformance
- Product and Establishment Registrations
- US Agent for foreign device companies
NWRS conducts and monitors clinical trials and prepares 510(k) and PMA submissions for class II and III devices, and we have taken companies through successful notified body audits for CE mark, ISO 13485, and CMDCAS certifications.
The NWRS staff takes pride in providing immediate and personalized attention to our clients, and we are sensitive and responsive to deadlines, details, and budgets. NWRS offers competitive rates by minimizing overhead.
STRATEGIC APPROACHES
There are many aspects to successful market entrance for new medical devices. Ensuring that your device design meets FDA performance criteria is critical to both your and our success.
Our background in diagnostics R&D, human factors, risk management and technical aspects of device design, combined with our knowledge of the type of data collection and presentation that the FDA requires, gives us powerful insights into the development pathways that will get you to market sooner.
A poorly planned submission can mean months of costly studies and review cycles. At worst, it means loss of a product investment and expected revenue. We apply our experience to help circumvent issues that the US FDA may raise during reviews to ensure that your device submission is acceptable.
At best, a declined submission means many months of costly studies and rewrites, and repeating the lengthy review cycle of resubmission. At worst, it means loss of a product and its related costs. We help ensure that your device submission is acceptable to the US FDA.
Strategic Planning from Concept to Market
Premarket Notification 510(k) Submissions
Premarket Approval Applications (PMA)
Investigational Device Exemptions
CRO Services
NWRS provides complete CRO services for your device trials, including:
CLIA Waivers
EU Compliance
Labeling and Advertising Review
FDA Representative/Official Correspondent
Compliance Crisis Management
EU MDD Compliance
QUALITY SYSTEMS SERVICES
Many companies feel constrained by quality system regulations. A quality system should fit like a well-tailored suit, not like a straight jacket. With the global elevation of regulatory standards and directives, it is prudent to build a quality system that is commensurate with the company’s regulatory footprint. NWRS can help!
We can build custom-tailored solutions and perform internal and inspection-readiness and gap assessment audits for compliance with 21CFR Part 820, MDSAP, MDD and ANVISA requirements.