Quality Management System Consulting

Quality Management System ConsultingMBC & Affiliates, Inc. (MBCA) provides innovative quality management system consulting, and regulatory compliance solutions that improve performance, eliminate inefficiencies, and increase compliance.

Customized, Practical Quality Management System Consulting solutions that Work for Your Organization

Quality and compliance do not come sold in a box.  Companies are required to establish a Quality System that is unique to the products they sell and the services they offer.  Successful companies invest in developing a Quality System that not only meets their regulatory compliance needs but also one that facilitates efficient business practices.  Such a Quality System is developed using real world expertise with the ever-changing regulatory environment today.

As medical device suppliy chains and markets are becoming increasingly dependent upon worldwide networks to be competitive on the global scale, companies must balance numerous regulatory requirements for specific countires or groups of countries.  Having an outsourced partner to help make sense of it all and keep your company’s Quality System current with worlwide requirements just makes good business sense.

MBCA provides real world quality management system consulting solutions that come from MBCA’s breadth and depth of knowledge and experience.  Our extensive areas of expertise allow MBCA to design a custom solution that’s right for your business needs.

Do you need help incorporating any of the following requirements into your Quality System?

  • 21 CFR Part 801 (US FDA-labeling)
  • 21 CFR Part 803 (US FDA-Medical Device Reporting)
  • 21 CFR Part 806 (US FDA-Corrections & Removals [Recalls])
  • 21 CFR Part 809 (US FDA-In Vitro Diagnostics)
  • 21 CFR Part 820 (US FDA-Quality System Regulation)
  • 21 CFR Part 11 (US FDA-Electronic Records, Electronic Signatures)
  • ISO 13485:2012 (ISO-Medical Device Quality System Standard)
  • ISO 14971:2012 (ISO-Risk Management Standard)
  • CMDR SOR 98-282 (Canada)
  • MDD 93/42/EEC (European Union Council Directive for Medical Devices)
  • PAL MHLW No 169 2004 (Japan)
  • ANVISA RDC No. 16/2013 (Brazil)
  • Therapeutic Goods Administration Medical Device Regulations (Australia)