Outsourcing
We are helping companies of all sizes enjoy the incredible benefits of outsourcing.
We will help you increase your productivity, streamline your process,
achieve efficiency and save money through outsourcing.
Medical device regulatory affairs and QA outsourcing is not limited to smaller companies.
Larger companies, even those with established QA/RA departments, often seek our assistance to supplement their in-house expertise, allowing them to overcome staffing shortages, accommodate a parental leave of absence, provide training, or obtain independent auditor assistance.
Whatever your situation, BioVision can help you maintain regulatory compliance, enhance your quality system, and most importantly, concentrate on your core business objectives.
Our quality assurance and regulatory affairs outsourcing services include:
• Temporary full-time, part-time, or "as needed" consulting for QMS compliance and regulatory affairs.
• Preparation of global regulatory submissions, 510k, Technical files, Health Canada, etc...
• Audits of your quality management system or a supplier's quality system.
• Review of corrective actions and recommendations for resolution.
• Supporting quality metrics and analysis as part of the management review meetings.
• Internal auditor training, risk management, quality system, or other training needs.
• Complaint handling, contract review, and surveillance audits.
• Document control and maintenance of the quality system.
• Responding to FDA 483 Observations, Warning Letters, and Notified Body audit findings.
