Providing Quality Management Expertise & Customized Training
Razalution consulting services cover the full range of quality systems initiatives, including:
- Internal process and quality system audits/assessments
- Pre-certification audits
- Document control
- Design control
- Manufacturing and production processes
- Standard Operating Procedure (SOP) development
- Supplier quality and purchasing controls
- Labeling consistency and accuracy
- Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Medical Device Regulation (IVDR) processes and systems
Razalution also provides customized training based on an organization’s requirements, to ensure teams are utilizing the current best practices.
We offer instruction on areas such as Quality System Regulations, ISO 13485 & ISO 14971, Medical Device Regulation (MDR) & In Vitro Diagnostic Medical Device Regulation (IVDR) compliance, auditing, validation, specific regulations, and related quality management topics. Whether sessions are delivered via classroom instruction or a learning management system, our training goes beyond theoretical approaches and provides instruction that’s directly applicable to a client’s business needs.
Ensuring that medical devices meet a high level of quality is a full-scale endeavour. The processes, testing, and documentation behind those products must follow a consistent plan and meet current regulations. Each member of an organization, from executives to resource suppliers, plays a role in how quality is factored into a company’s operations, and Razalution can help guide your company to making quality a repeatable and ongoing standard.