QA & Compliance
Design, assess, and implement quality systems, procedures, and documentation to meet U.S. FDA QSR/GMP, ISO standards, European Medical Device Directives, Canadian Medical Device regulations and other medical device authorities' requirements.
Qsite's personnel originates from the medical device R&D and manufacturing arena (Electrical, Software and Mechanical engineers) and has wide-ranging experience in the design process and the regulatory requirements. We will guide you in the design, manufacturing and the transfer from design to manufacturing according to the regulatory requirements.
Key QA Services:
- Implementation of quality systems, procedures
- Documentation processes to meet international regulatory requirements.
- Corrective and preventive action programs
- Design control, including risk management and design validation
- Document control systems
- Software quality assurance
- External compliance Auditing
- Due diligence
- U.S agent
- Assign a US address, phone and fax for non-US companies
- Assist the FDA in communicating with international medical device companies
- Receive documents from the FDA on behalf of your company
- EU Authorized Representative
- Notify your product to the Competent Authority in order to apply for CE-Marking
- Provide a European Business Address as required by the Directive
- Maintain the technical documentation for routine inspection by the European Competent Authorities
- Ensure the communications between the European Competent Authorities and the manufacturer
- Observe the manufacturer's compliance with the European Directive
- Supply the competent authority with a Medical Device Report (MDR) as required
The FDA requires all foreign firms wishing to market medical products in the USA to appoint a US agent. Accordingly, we can provide these services:
The European Union requires all foreign firms would like to market medical products in the EU to appoint an Authorized Representative to be responsible towards the European Authorities for all European Regulatory Affairs.
The European Representative address must appear on the product label, or the outer packaging, or instructions for use. Qsite can provide these services.
