Regulatory Services

Regulations, Standards, and Quality Systems

• Assistance in meeting FDA, ISO, and EU regulations
• Assistance in choosing appropriate standards
• Establishing Quality Systems
• Preparing regulatory submissions
• Preparing regulatory files
• Representing your company at regulatory offices

Training

• Training classes on hardware and software reliability, human factors, standards and regulations, internal auditors.

Auditing

• Gap assessment audits in preparation for FDA or Notified Body audits.

HIPAA Compliance

• Assistance in developing and maintaining HIPAA compliance

Act as an Expert Witness

• Provide product liability services to ascertain the quality and reliability of a device or process.