Regulatory Services

The experts at the SteriPack Group stay up-to-date with the latest regulations and standards, to provide Customers with the most relevant and reliable medical device guidance. When introducing a new product to the market, Customers can choose to oversee the relevant regulatory requirements or hand responsibility to CMO. SteriPack offer expertise and advice on localised medical device regulations during the approval of products, at every stage of their development. The SteriPack Group is qualified to advise on:

Contract regulatory advice:

  •  CE marking
  •  Device regulation
  •  510k submission
  •  Consulting services for sterilisation and test methods 

FDA regulations:

  •  FDA regulatory strategy
  •  FDA device Classification
  •  US FDA 510(k) preparation
  •  UDI compliance consulting
  •  FDA QSR implementation
  •  US agent representation

EU Regulations:

  •  Device registration
  •  European CE marking Strategy for Medical Devices
  •  CE technical file or design dossier compilation and review
  •  European medical device classification
  •  European authorized representative for medical device companies

QMS Compliance:

  •  ISO 13485 audits for medical Device
  •  ISO 13485 consulting and implementation for medical device manufacturers
  •  ISO 13485:2016 consulting and gap analysis
  •  QMS compliance for startup medical device companies
  •  Short term or part-time medical device QA/RA outsourcing
  •  Medical device gap, internal, pre-certification and supplier QMS audits
  •  ISO 14971 risk management consulting for medical device

Testing and Validation:

  •  Material and chemical characterization testing for medical devices
  •  Gamma, e-beam, X-ray and EO processes validation
  •  Software validation (GAMP5)
  •  Sealing process validation

SteriPack's expertise:

CE marking of medical devices up to Class IIb and 510K submission.

Medical device contract manufacturing