Medical Devices

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Medical device innovation requires every decision to balance performance, safety, quality, compliance, and long-term adoption considerations.
GSAP helps manufacturers navigate global regulatory requirements, streamline development, and build the systems, evidence, and processes needed to bring safe and effective products to market

Standing over a medical device

How We Support Medical Device Companies

 

  • Product Planning & Regulatory Strategy
    Product classification, regulatory strategy development, regulatory planning, and clinical strategy support aligned with global medical device requirements
  • Design, Development & Verification
    Support for design and development activities, design controls, verification and validation (V&V), pre-clinical studies, clinical studies, and product testing programs
  • Regulatory Submissions & Market Authorization
    Preparation and review of technical documentation, regulatory submissions, device registrations, and interactions with regulatory authorities, notified bodies, and competent authorities
  • Quality Systems & Lifecycle Compliance
    Development, implementation, and maintenance of Quality Management Systems (QMS), risk management programs, supplier controls, CAPA processes, complaint handling, and post-market compliance activities
  • Cybersecurity, Privacy & Software Documentation
    Development of software lifecycle documentation, traceability and compliance frameworks, together with cybersecurity, privacy, and information security programs supporting regulatory compliance and lifecycle management
  • Clinical Strategy & Evidence Generation
    Clinical strategy development, clinical documentation, study support, monitoring activities, and generation of clinical evidence in accordance with applicable regulatory and clinical requirements
  • Validation & Manufacturing Readiness
    Process validation, manufacturing transfer, production readiness, equipment qualification, validation planning, and manufacturing support activities
  • Engineering, Validation & Facility Development
    Support for facility design, qualification, validation, process validation, cleaning validation, and GMP-compliant manufacturing infrastructure
  • Audits & Inspection Readiness
    Internal audits, supplier audits, regulatory inspection preparation, mock audits, and ongoing compliance readiness activities