Quality Assurance

Having a Quality Management System (QMS) that meets the regulation and is designed to be as least burdensome is a key to an efficient, easy to maintain, constantly improving QMS.

KeyMedic offers Quality Assurance solutions, including:

  • QMS Establishment: defining the scope of the quality system, developing efficient, user-friendly policies & Standard Operating Procedures (SOPs), selecting and customizing QMS software.

  • QMS Implementation:

    • Design & Development Control: design and V&V planning, preparation / review of testing protocols and reports, locating laboratories for product testing, transfer to production and process validation.
    • Risk Management: risk management planning and risk analysis, according to ISO 14971 (2019).
    • Production Control: purchasing control, production work instructions review, management of non-conformities.
    • Supplier Control: supplier qualification, supplier evaluation plan, supplier / subcontractor / distributor audits / quality agreements.
    • Quality Planning & Compliance: defining quality objectives and KPIs, internal audits, CAPA planning and execution, management and employee training, data analysis and management review.
    • Post Market Surveillance (PMS): PMS planning, preparing / reviewing PMS reports, management of warning letters.
  • Preparation for QMS Certification gap analysis, mock inspections, audit behavior employee training, audit operation management:

    • ISO 13485 audits
    • Medical Device Single Audit Program (MDSAP) audits
    • FDA inspections
    • MFDS (S. Korea) inspections
    • INMETRO (Brazil) audits
    • And more
  • QMS Maintenance on-demand hands on service:

    • Evaluation of Corrective Action Effectiveness
    • Review of data integrity
    • Specific, on-demand trainings
    • Complaints management
    • Control of measuring equipment
    • Internal audits
    • Facility environmental control
    • Preparation for surveillance audits
    • Maintenance of product files
    • Mentoring of QC and QA staff
    • Preparing / reviewing periodic reports
    • And more
What We Do

KeyMedic provides consulting services to the medical device industry, specializing in regulatory, quality and compliance solutions.

To help you even more we collaborate with Parente Studio, a Design and Development company that can help bring your company and product to the highest professional level.

Strategic Regulatory Consulting

Strategic regulatory consulting, development of regulatory plan, clinical investigations, regulatory submissions and more.

Quality Management Systems

Establishment and implementation of Quality Management Systems, inspection preparation & readiness assessment and more.

Quality & Regulatory Complience

Design control, V&V, risk management, quality audits, post market surveillance, recall management and more.

Branding, Design & Development

Branding, Logo, Business Cards, Product & Packaging Design, Website, Conference Booths, Ads, Brochures, Labeling, Patient Leaflets, User Manuals and more.