• (619) 515-4556
  • paradigm@qualityconsulting.com

FDA and ISO consultants to Medical Device developers and manufacturers

FDA and ISO consultants to Medical Device developers and manufacturers

Comprehensive QMS Consulting Services Tailored to Your Needs

All services rendered and work-product is fully compliant with the following current medical device normative references:

  • CGMP of the US FDA Quality System Regulation (CFR Title 21 Part 820), and related guidance documents.
  • International Standard ISO 9000:2015 (Quality management systems – Requirements).
  • International Standard ISO 13485:2016 (Medical devices – QMS – Requirements for regulatory purposes).
  • International Standard ISO 14971:2007 (Application of risk management to medical devices).
  • EU Medical Device Regulation 2017/745 (replaces MDD Directives 93/42/EEC and 90/385/EEC).
  • EU In Vitro Diagnostic Device Regulation 2017/746 (replaces Council Directive 98/79/EC).

From one central and trusted source, our array of services includes systems development, QMS implementation activities, non-compliance remediation, audit services, and a host of other QA / QE activities. These services include, but are not limited to, the following:

  • Strategic management consulting relative to your QMS
  • Quality Management System development
  • Facilitation and management of new ISO certification projects
  • Assistance in selecting an ISO Registrar
  • Facilitation of ISO transitional certification projects (e.g.9001:2008 to 9001:20)
  • Collaborative QMS documentation development (Quality Manual, Policies, SOPs, Forms, Records)
  • Review / revision of existing QMS documentation
  • External audit preparation / pre-audit training (FDA, ISO, or customer)
  • Representation during FDA audits (pre-approval, routine, follow-up compliance, “for-cause”)
  • Representation during ISO audits (surveillance or certification)
  • Internal Compliance Audits (to your schedule, or independent “3rd party”)
  • Supplier audits / supplier assistance
  • Supplier rating programs
  • Quality Assurance / Quality Engineering activities (development or assistance with)
  • Design History Files
  • Device Master Records
  • Device History Records
  • Design Control support
  • Risk Management / Assessment
  • FMEA / FMECA
  • Design of Experiments / Process V&V
  • Root-cause analysis
  • Corrective and Preventive Action
  • Management Review
  • Complaint Handling System
  • Electronic Signatures / Records
  • Material Review Board
  • Supplier Performance Assessment
  • Sampling (attribute, variable)
  • Inspection (incoming, in-process, final)
  • SPC methodologies

Paradigm Consulting Services will tailor our work-product to your particular needs, and in support of your particular time-frame. We will structure our work-efforts in a way that makes the most sense for you:

  • Remote document review and draft revisions (see Contact page for more details)
  • Single-event session (remote or on-site)
  • Strategy meetings (remote or on-site)
  • As-needed support (remote or on-site)
  • Project-specific support (remote or on-site)
  • Element-specific support (remote or on-site)
  • Retainer arrangement (remote or on-site)