Accurate Consultants Inc.
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Business & Professional Services
Medical Devices & Diagnostics/IVD's
Regulatory Affairs Solutions
Our consultants have extensive industry experience in preparing submissions and have an excellent track record for interfacing with the appropriate regulatory authorities and helping firms achieve their regulatory objectives. We specialize in the following Regulatory Services:
Medical Devices and IVD Submissions
• Pre-Submissions (Pre-subs/Q-Subs)
• Pre-Market Notifications (510(k))
• Pre-Market Approval (PMA)
• PMA Supplements (30-day/135-day, 180-day, Real Time, Special, Panel Track) and Annual Reports
Quality System Solutions
Accurate Consultants will immediately supplement your organization to provide various quality system solutions, which will comply with ISO 13485:2016 Quality Management System Regulation (QMSR) as well as International Regulatory Authorities regulations and standards such as EU Medical Device Reporting (MDR). Accurate Consultants can engineer and supply you with the appropriate QMSR or EU/MDR compliant documentation and training. Our Quality System solutions can be customized and implemented into your organization in a seamless way for simplicity and for long term sustainability.
Compliance Solutions
Accurate Consultants offers third party audits, Mock FDA inspection audits, Regulatory Gap Analysis audits, Internal and External Supplier audits and 483/Warning Letter Response and Remediation. We also offer Labeling Review, Risk Management, CAPA support, import/export assistance, establishment registration and device listing.
Training Services
Accurate Consultants offers a full complement of training programs for all levels of an organization from senior executives to bench technicians, to cleanroom operators to manufacturing personnel, Quality Assurance (QA) and Quality Control (QC). Training programs can be customized to meet each organization’s requirements. In addition to virtual or onsite lecture format training, Accurate Consultants is also able to deliver on-the-job training and “train the trainer” services.
Regulatory Affairs Solutions
Our consultants have extensive industry experience in preparing submissions and have an excellent track record for interfacing with the appropriate regulatory authorities and helping firms achieve their regulatory objectives. We specialize in the following Regulatory Services:
Medical Devices and IVD Submissions
• Pre-Submissions (Pre-subs/Q-Subs)
• Pre-Market Notifications (510(k))
• Pre-Market Approval (PMA)
• PMA Supplements (30-day/135-day, 180-day, Real Time, Special, Panel Track) and Annual Reports
Quality System Solutions
Accurate Consultants will immediately supplement your organization to provide various quality system solutions, which will comply with ISO 13485:2016 Quality Management System Regulation (QMSR) as well as International Regulatory Authorities regulations and standards such as EU Medical Device Reporting (MDR). Accurate Consultants can engineer and supply you with the appropriate QMSR or EU/MDR compliant documentation and training. Our Quality System solutions can be customized and implemented into your organization in a seamless way for simplicity and for long term sustainability.
Compliance Solutions
Accurate Consultants offers third party audits, Mock FDA inspection audits, Regulatory Gap Analysis audits, Internal and External Supplier audits and 483/Warning Letter Response and Remediation. We also offer Labeling Review, Risk Management, CAPA support, import/export assistance, establishment registration and device listing.
Training Services
Accurate Consultants offers a full complement of training programs for all levels of an organization from senior executives to bench technicians, to cleanroom operators to manufacturing personnel, Quality Assurance (QA) and Quality Control (QC). Training programs can be customized to meet each organization’s requirements. In addition to virtual or onsite lecture format training, Accurate Consultants is also able to deliver on-the-job training and “train the trainer” services.
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