About MBCA

About MBCA – Medical Device Compliance Solutions

Learn more about MBCA as a provider of medical device consulting services.  MBCA’s mission is to provide comprehensive yet practical medical device compliance solutions including training & education, regulatory affairs assistance, regulatory compliance advice, and Quality System support.

MBCA provides medical device compliance solutions for Class I, II, and III Medical Device Companies including the In Vitro Diagnostics Market and Medical Device Data System companies.

Specifically, MBCA’s medical device compliance solutions help clients:

  • Introduce new and revised products to the market
  • Improve business performance by creating compliance solutions that increase efficiency as well as effectiveness
  • Reduce our clients’ regulatory compliance risks to help them better demonstrate compliance to Third Party Agecies like the FDA and Notified Bodies.
  • Manage thier key suppliers efficiently and in a cost-effective way
  • Provide cGMP Training, Internal Auditor Training, and Lead Auditor Training
  • Perform Quality Audits to support our clients’ Quality Management Systems and Supplier Quality programs

A Business Approach

Companies often struggle with how to comply with regulations while operating an efficient business. The two are not in conflict but dependent upon one another. MBCA provides customized and practical medical device compliance solutions that make sense for the types of products you make. MBCA helps you find the right balance between compliance and efficiency that will help you succeed in this highly regulated industry. Finding this balance brings the following benefits to the company:

  • More effective processes
  • More efficient processes
  • Increased product quality
  • Decreased scrap over time
  • Elimination of recurring manufacturing problems by focusing on root causes
  • Drastic reduction in supplier problems by performing supplier quality consistently
  • Increased customer satisfaction
  • Faster throughput

About Melita Ball, Principal Consultant

Melita Ball, Principal Consultant

Ms. Ball is a Regulatory & Quality Systems professional with over 25 years of experience in Quality Systems and Regulatory Compliance.

She has particular expertise in establishing compliant quality systems based on  ISO 13485,
ISO 14971, Canadian Medical Device Regulations, MDD, 21 CFR Parts 11, 801, 803, 806, 809, 810, 812, and 820, Brazilian Medical Device Regulations, JPAL, and Australian Medical Device Regulations.

She is an internationally recognized expert in providing medical device compliance solutions, training & education, and regulatory services for medical device, in vitro diagnostic, and medical device data system companies.

She specializes in delivering customized, comprehensive, and practical medical device compliance solutions for companies around the globe.  Feel free to browse MBCA’s website to learn more about specific services offered or Schedule FREE 30 minute consultation »

 

Consulting Services in the Following Areas:

  • Regulatory Affairs

    • Write, deliver, and defend new product submissions.
  • Quality System

    • Build & implement quality systems for clients
    • Perform remediation for quality system elements that are no longer effective
    • Establish FDA enforcement action mitigation plans for clients.
  • Quality System Training

    • Create customized and public courses
    • Deliver course content in an engaging atmosphere
    • Trainer share real-world experiences to drive topics home
  • Database, Software Validation, and Part 11

    • Create & deliver validated custom databases to support client’s specific needs
    • Assist with software validation and Part 11 implementation projects
  • Lead Auditing

    • Conduct Internal, 3rd Party, and Supplier audits for clients around the globe