Canada
QualMed is comprised of professionals with greater than 15 years experience in the medical device and pharmaceutical industries. They have worked with both small entrepreneurial organizations and large well established medical device and pharmaceutical organizations.
Direct experience working with Health Canada, the US FDA, Europe and several Asian authorities means that QualMed is well versed in all new regulations and guidances concerning Good Distribution Practices, WEEE, RoHS and supplier management.
QualMed has conducted audits and gap assessments in Canada, the US and Europe. In whatever they do, they attempt to understand the needs and constraints of your organization and provide the best solution.
Services
QMS Development
Support the development of your Quality Management System or improve the existing system.
On-site Customized Training
They 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, they 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. They will provide insight into the challenges and opportunities the organization is facing.
Regulatory Support
They can support the development and submission of regulatory files for Health Canada, FDA, Technical Files and Asian dossiers.
