Services Designed to Bring Vision & Strategy to Life
Our mission is to partner closely with organizations, providing expert fractional leadership in quality and regulatory affairs. We help drive enterprise alignment and ensure excellence by optimizing QMS and regulatory infrastructure to meet industry standards and regulatory requirements.
Leadership & Business Strategy Support
Our collaborative approach involves partnering with you to streamline organizational structure, delineate roles and processes that align with strategic goals, enhance agility, and optimize efficiency. We specialize in navigating organizational and process transformations seamlessly, providing tailored change management strategies to ensure smooth transitions and alignment with your overarching strategic vision.
Quality Strategy
Organizations, particularly smaller start-ups, often need an experienced partner to help establish, implement and optimize the Quality Management System across throughout all phases of the lifecycle to ensure the safety and effectiveness of the medical devices that are being developed compliant with the applicable regulatory standards. We offer complete quality support covering every stage of the medical device lifecycle, from initial product development through to post-market surveillance and beyond.
Our areas of expertise include:
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Design Control: We assist in establishing and maintaining robust Design Control processes to ensure that your design and development activities are conducted in accordance with regulatory requirements and industry standards.
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Risk Management: Our team conducts comprehensive risk assessments and helps you implement effective risk management strategies to identify, mitigate, and monitor potential risks throughout the design and development process.
- Regulatory Compliance Audits and Gap Analysis: Conduct regulatory compliance audits and gap analyses to assess the company’s current practices against regulatory requirements and identify areas for improvement. Strategic Company Due Diligence and QMS Integration Support.
- Quality Management System (QMS) Assessment, Optimization, Maintenance & Remediation: Implementation or optimization of all elements of the QMS in compliance with applicable regulatory requirements New eQMS system project management and QMS process development for seamless eQMS deployment.
- Post-Market Surveillance and Reporting: Establish and or/optimize post-market surveillance systems to monitor the safety and performance of medical devices after they have been commercialized. This can include assisting in the timely reporting of adverse events, complaints, and product recalls to regulatory authorities.
- Post-Market Compliance: Responding to and developing action plans related to regulatory agency audit findings.
- Post-Market Compliance Analytics: Collate and analyze quality product and compliance metrics for quality business and management review data packages.
- Regulatory Intelligence and Updates: Monitor regulatory developments, guidelines, and policy changes to keep companies informed about evolving regulatory requirements and potential impacts on their products and operations.
Regulatory Solutions
From development and implementation of regulatory strategies, to due diligence, to submission and pre-submission preparedness, to product development support, we offer regulatory solutions and strategies tailored to the specific needs of each of our clients in the medical device industry. This includes determining the appropriate regulatory pathways for your company and your requirements for market clearance or approval.
Quality & Regulatory Training
We work with organizations and teams to develop and deliver customized Quality & Regulatory training depending on the need of the business. By focusing on QA& RA principles in the medical device field, we help our partners drive quality and regulatory excellence and help build a strong quality culture across the organization.
Executive Coaching & Mentoring
