Quality and Regulatory Consultancy

Simplimedica is a consultancy firm that believes in a long-term partnership. We support short-term, medium-term, and long-term project work for small and medium-sized businesses, as well as large corporations that may have a shortage in a skill or wish to outsource work to improve productivity.

We help companies establish quality management systems (QMS) compliant with medical device industry standards.  We also provide guidance where regulatory requirements can be overwhelming and confusing. Simplimedica is a one-stop solution for ensuring that your company’s medical devices are firmly on track for being approved for sale in target markets. The following are some of the services  we can provide to your  company:

• Quality Management System & CE Marking

• Regulatory Services

• Auditing Services

• Risk Management

• Design Control

• Validation

• Audit Remediation

• Our Medical Device support services cover Class I, II, and III as well as IVDs