Client Services

Quality and regulatory consulting for all aspects of medical device documentation and quality management system compliance.
Reference Standards and Regulations
  • EN ISO 13485:2016
  • ISO 9001:2015
  • CFR Title 21, Part 820
  • FDA 21 CFR Part 11
  • EN ISO 14971:2019
  • ISO 19011:2018
  • MDSAP Audit Approach: MDSAP AU P0002.008
  • MDD 93/42/EEC
  • MDR 2017/745
  • Canada: CMDR SOR/ 98-282
  • Brazil: GMP RDC ANVISA 665/2022
  • Australia: Therapeutic Goods Medical Devices TG(MD)R
  • Japan: JPAL MHLW MO169
  • ISO 11137-1
  • ISO 11135
  • Additional standards including healthcare packaging, transit testing, and product specific standards.
Engineering Support
  • Design controls – compliant DHF and DMR
  • Risk management
  • Validation protocols (IQ/OQ/PQ) and revalidations
  • Software validations
  • Biocompatibility risk assessments per ISO 10993
  • Technical files
  • Clinical Evaluation Reports
  • Mitigation for internal and external audit findings including FDA 483 and warning letters
  • Training on all aspects of regulations and compliance​
​Health Canada Registration & Licensing
  • Establishment Registration (Class I)
  • Medical Device Licensing (Class II) & PVL
Quality Management System (QMS)
  • Review of existing QMS for compliance
  • Develop and implement QMS tailored to customer needs and size of company
  • Document control and good documentation practices, including FDA Part 11
  • Execution of compliant and effective Management Reviews and risk-based process management
  • Execution and training for fully compliant Internal Audits per ISO 19011:2018
  • Developing and training on fully compliant CAPA systems for enhanced QMS compliance
  • Mitigation for internal and external audit findings including FDA 483 and warning letters
  • Training on all aspects of regulations and compliance
Product Life Cycle
  • Design and implement effective post market surveillance activities
  • Design changes and compliant documentation​
Facility Start-up, Expansion or Relocation
  • Relocation of facilities or new facility validations​
Regulatory Transition Support
  • EN ISO 13485:2016 - Initial certification
  • MDSAP transition and audit support​
  • EU MDR Transition from MDD