The Medical Device Single Audit Program (MDSAP) and ISO standards have become essential components of quality system compliance for device manufacturers operating internationally. Our approach focuses on conducting thorough, systematic evaluations that examine your quality management system against these harmonized requirements. We help you identify and address compliance gaps while preparing your organization for successful certification audits and ongoing compliance with multiple regulatory authorities.
Our MDSAP and ISO auditing services include, but are certainly not limited to:
Comprehensive evaluation of quality systems against the harmonized MDSAP audit model.
Detailed assessment of compliance with the international quality management system standard for medical devices.
Mock certification audits to prepare for upcoming MDSAP or ISO certification assessments.
Support addressing findings from official certification audits.
Targeted evaluations of specific processes against MDSAP and ISO requirements.
Guidance on establishing compliant systems that satisfy MDSAP and ISO standards.
Assessment of device technical files and design dossiers against regulatory requirements.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant/contractor (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
