Strategic Regulatory Planning

Strategic Regulatory Planning

  • Developing a regulatory strategy depending on the product and desired market, including classification of device
  • Selecting the appropriate Notified Body for your product
  • Gap-Analysis – identifying and reviewing gaps in regulatory compliance
  • Periodic Standards Review
  • MDR 2017/745 readiness assessment and transition strategy
  • Regulatory Due Diligence for projects and prospective acquisitions
  • Full registration in global markets, including set-up of technical documentation:
    1. Europe – CE Marking – Technical Files (Class II) & Design Dossiers (Class III):
      • MDD 93/42/EEC amended by 2007/47/EC
      • AIMDD 90/385/EEC
      • MEDDEV 2.7/1 rev. 4 – Clinical Evaluation Report (CER)
      • Biocompatibility Risk Assessment – EN ISO 10993-1:2018
      • Developing and implementing Risk Management programs – EN ISO 14971:2012
      • Design Control – DHF
      • Verification & Validation activities & evaluations
      • IQ/OQ/PQ
      • PMS activities (including Vigilance – reviewing & reporting incidents, field actions and adverse events)
      • PMCF – MEDDEV 2.12/1 rev. 8
      • MDR 2017/745 Gap-Analysis
    1. USA – FDA:
      • FDA 510(k) submissions & pre-submissions for implants
      • MAF submission for new biomaterials
      • eCopy preparation
    1. Canada – Health Canada MDL & MDEL submissions
    2. China – CFDA Regulations submissions for Class II & Class III medical devices
    3. Israel – AMAR Registration
    4. Brazil – ANVISA Registration
    5. Argentina – ANMAT Registration
    6. Colombia – INVIMA Registration
    7. South Africa – SAPHRA Registration