Regulatory Support

Regulatory and Project Planning

Services include translating regulatory strategy into a project plan, including pre-clinical and clinical deliverables

  • Defining requirements for product development as required by FDA and ISO Quality System regulations
  • Guidance on preclinical testing (bench, animal) based on FDA Quality System requirements (QSr), ISO, IEC and other applicable software, electrical, EMC, safety, biocompatibility, sterilization, packaging, shipping and industry standards
  • Defining regulatory requirements for clinical studies based on Good Clinical Practice (GCPs), ISO 14155 & IDE regulations