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Consulting 
Services

MedQuality International offers a full list of services to complement your quality system and meet your business needs.  

Quality Auditing

  • Extensive experience as a Lead Auditor managing all aspects of the audit preparation, execution and reporting.

  • Internal, Supplier and Mock Auditing to support the entire life cycle of medical device and pharmaceutical products.

  • Inspection Readiness focused preparation approaches; remediation of 483s and non-conformities; advice on the process of hosting audits/ inspections.

  • Manage all quality system audits throughout the organization by planning and communicating the audit schedule and outcomes, tracking metrics related to audits and quality system management, ensure timely closure of all audits and maintaining compliance to all regulatory requirements. 

  • Provide hands-on coordination and support for execution of the nonconforming product (NCR) and corrective and preventive actions (CAPA) processes.

  • Provide hands-on coordination and investigation of product failure investigations from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed.

  • Train and educate others on quality-system requirements, audit processes, audit preparation, audit-readiness, and good documentation practices to help ensure compliance.

  • Expertise in regulations and standards:

    • US FDA:  21 CFR 820, 21 CFR 210/211, 21 CFR Part 4

    • Medical Device Single Audit Program (MDSAP)

      • Australia, Brazil, Canada, Japan, USA

    • EU:  MDR  2017/745, IVDR 2017/746

    • ISO:  13485:2016, 9001:2015

    • Many more countries, regulations, and standards

2

Quality Assurance

  • Expertise on the design, implementation, monitoring, and maintenance of Quality Management Systems according to ISO 13485, MDSAP, MDR and other relevant regulatory requirements.

  • Serve as Quality Representative and/or Quality Assurance Head for client organizations.  Function as head of QA/RA for client organizations within the client company.  Represent the client in regulatory meetings and engagements.

  • Plan, implement and manage ISO 13485:2016, MDSAP and MDR transitions and integrations.

  • Implement electronic Quality Management System software and integrate a paper QMS into an electronic QMS.

  • Host Management Review process, customer business reviews, customer issues and audits, and regulatory inspections.

  • Expertise in Risk Management and Design Control systems.

  • Software as a Medical Device and software validation review and submission readiness assessments.

  • Expertise in CAPA system design, improvement, and management.

  • Review technical protocols, analytical data and reports for validations, engineering specifications, engineering verification and validation reports, and production and manufacturing processes.

  • Establish quality and business metrics to demonstrate the performance and effectiveness of the QMS. 

  • Perform strategic contractor searches, negotiations, and qualifications for outsourced services.

  • Provide training on government regulations, new or revised policies and procedures, and process and equipment instructions.

  • Advice on Design History Files, Device Master Records, and Product Design Dossier / Technical Files including gap assessments to applicable regulations.

  • Design and manage product and process validations, shipping & packaging validations, cleanroom qualifications, equipment qualifications, facility expansion projects and other projects as required.

  • Approve and manage Supplier Management Program that includes all material, service and contract manufacturing suppliers.

  • Track and trend plant quality metrics such as scrap, complaints, CAPAs, OTD, material variances, MRB and cost of quality for lean business practices and continuous improvements.

  • Manage and approve all internal and external contract manufacturing vendors and events.

3

Regulatory Affairs

  • Expert advice and training on the interpretation of the Medical Device Directives, EU Medical Device Regulation, MDSAP (US, Canada, Japan, Brazil, Australia) and other country regulations pertaining to medical devices.

  • Review, edit, and author FDA 510(k) submissions along with EU CE Technical Dossier submissions.

  • Assist with problem resolution, regulatory clearance, and business expansion of IVD, Class 1, Class II, and Class III medical devices, including combination products and implantable devices.

  • Manage all regulatory registrations and certifications for company.

  • Post-Market Surveillance report creation, review, and management.

  • Complaint, Adverse Event, Advisory Notice, and Field Corrective Action support, review, and management.

  • Expert advice on selection, process, and preparation of a new Notified Body (initial certification and transfers)

  • Develop quality reports and metrics to support assessments of quality system effectiveness and product line goals and objectives.

  • New product design and strategy development and project management through regulatory clearance.

4

Acquisition and Merger

  • Lead and Manage technology innovation, product development efforts and manufacturing operations and ensuring alignment with corporate, financial, strategic, and organizational goals Strategic business development and expansion planning.

  • Evaluate the Quality Management System (QMS) at all acquired businesses.

  • Develop and implement the appropriate plan to integrate acquired businesses into the existing QMS.

  • Oversee the development and transition of facilities into the existing QMS.

  • Design and update the company QMS to reflect new processes and systems from acquisitions.

  • Drive a culture of quality and safety throughout the organization.

  • Manage and perform due-diligence audits.

  • QMS harmonization between acquired facilities.

5

Supplier Management

  • Supplier evaluation, qualification and audit.

  • Supplier project management and oversight.

  • Voice of the Customer representative / In-Plant representation.

  • Assistance with design project management and completion.

  • Assistance with design and manufacturing issues.

Get in Touch

Phoenix, Arizona

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