Regulatory

At Paul L Clark & Associates, our knowledge and experience is based on more than 20 years within the MedDev industry,  working on both sides of the fence for various regulatory agencies and MedDev companies. Our background includes the Therapeutic Goods Administration (TGA), TUV Product Services, the Canadian Medical Devices Bureau, and various roles in senior management with start-up and medium sized MedDev companies. We have detailed working knowledge and understanding of the Food and Drug Administration (FDA), having successfully prepared and managed IDEs, 510ks, PMAs, MDRs, recalls and compliance to the US quality system regulations (21 CFR 820) / code of Good Manufacturing Practice (cGMP). We have successfully managed a number of ISO13485 / Medical Devices Directive (MDD) certifications for European CE marking, TGA product registrations, Canadian Medical Device License applications and various other international approvals. We have the capabilities to offer a full range of domestic and international regulatory services, including:

• International regulatory strategies
• TGA product registration
• 510k / PMA submissions
• FDA compliance assessment & gap analysis
• Development of MDD & IVDD technical files/design dossiers
• Compilation of clinical evidence
• Medical device reporting (MDR), health hazard assessment and product recall management
• Post market surveillance and vigilance reporting