42 TechnologyPracticesRegulatory

Regulatory

Designing and launching products in a heavily regulated environment requires detailed planning and knowledge of the requirements of each particular market and industry sector.

There are so many relevant standards to recognise and apply – ISO13485, ISO14971, IEC60601, IEC62304, IEC62366, 21 CFR 820, 21 CFR 11 to name but a few.

42 Technology is certified to ISO9001 and ISO13485 and provides assistance to a wide range of companies looking to launch globally applicable products.

Our activities include:

  • Regulatory road mapping
  • Correct and efficient application of design controls
  • Software development to regulatory standards
  • Creation of design history files, risk management files, EU technical files
  • Human factors engineering studies
  • Process validation
  • Supplier selection, auditing and development

We frequently work within our client’s project teams, helping the creative engineering process to proceed without unnecessary delays due to regulatory hold ups.

We can also provide on-site training, process improvement workshops, audits and gap analysis to ensure that your development team is aware of the requirements of regulatory authorities and is fully compliant.