Quality System Development

Quality System Development

We have developed and implemented complete quality management systems (QMS) for clients. Many of whom also achieved ISO Certifications to ISO 13485, CAN ISO 13485, and ISO 9001. All the quality management systems we develop are in compliance with FDA regulations, ISO Standards, Canadian Medical Device Regulations, MDD, IVDD, AIMDD, MDR and MDSAP. We develop a QMS that is tailor-made for your organization depending on the scope of your products and your marketing goals.

Internal and Supplier Audits

Does your organization already have a quality management system developed and documented? How well has it been implemented? Our team of auditors currently assists numerous clients by conducting internal and supplier quality audits as well as mock FDA inspections. We provide your firm with a thorough evaluation of your processes and from an objective perspective determine how well the processes have been implemented. Our auditors are experienced and qualified to assess your organization’s compliance with FDA regulations, ISO Standards, Canadian Medical Device Regulations, MDD, IVDD, AIMDD, EU MDR, and MDSAP (all country-specific regulations).

Quality Management

Gap Analysis and 3rd Party Audit and Inspection Preparation

Regulations, standards, and directives are in a constant state of flux and manufacturers need to be prepared to implement quality system changes in order to achieve and maintain compliance. Our team of consultants has extensive industry experience and is available to help identify gaps and potential deficiencies in your quality system. We take a consultative approach to gap analyses so you and your personnel are able to learn from the experience in a comfortable and informal environment as you prepare for upcoming 3rd party audits and inspections. Some areas where we are actively assisting clients include gap analysis against FDA Regulations, ISO 13485:2016, MDSAP, Canadian Medical Device Regulations, and the new Medical Device Regulation for Europe.

Quality System Training

We offer customized training seminars covering all areas of the quality management system. Our seminars include FDA, ISO and CMDR quality systems as well as more detailed sessions on complaint handling, design and development, process controls, corrective and preventive action or any other element of the quality system

Other services include:

  • Facilitation of FDA inspections
  • Unique device identifier (UDI)
  • Electronic quality management systems development and validation
  • Process mapping