QMS Development
Support the development of your Quality Management System or improve the existing system.

On-site Customized Training
We can deliver training customized for your need on the following topics: ISO 13485:2003, FDA QSR, MDD 93/42/EEC, IVD Directive 98/79/EC, Risk Management, International Regulations, Design Control, and Supply Chain Management.

Auditing or Gap Analysis
Whether in fulfillment of your existing QMS requirements or supplier management activities, we can conduct audits or a gap analysis to identify areas for improved effectiveness.

Quality Due Diligence
Investing in an organization requires an extensive understanding of an organization’s products and processes. We will provide insight into the challenges and opportunities the organization is facing.

Regulatory Support
We can support the development and submission of regulatory files for Health Canada, FDA, Technical Files and Asian dossiers.

Lean Machine SoftWare
QualMed is proud to support The Lean Machine www.theleanmachine.com, a suite of products that are comprehensive in their capabilities but inexpensive and they eliminate the need for in-house databases and spreadsheets.  They have been designed to meet the needs of smaller, earlier stage organizations that have a need for structure but cannot afford or have a need for larger enterprise solutions.  The Lean Machine gives users a structured system for document control including Bill of Materials management, Quality System management including CAPA, Internal Audits, Calibrations and much more.  The intuitive design of the system makes the system relatively inexpensive and quick to implement.  Further, validation templates are available to ensure your system complies with FDA and Health Canada requirements for electronic systems.  Contact sales@Qualmed.ca today to arrange a demonstartion.