Eisner Safety Consultants is poised to assist you helping to reduce costs, travel expenses / time, and providing an option to onsite audits when impractical
Medical device manufactures are the lifeblood that supply the healthcare system. Thank you for your support of our healthcare system. In times of pandemic, hurricanes, earthquakes, sickness and other situations we may not be able to conduct in person audits. Internal audits are a requirement for maintaining your medical device quality management system (i.e. ISO 13485, FDA, MDR, etc.).
Our experts are ready and able to provide remote auditing services to help you keep your regulatory compliance of your QMS on track and not “slip off the rails”. We can perform a variety of audits of your or your supplier facilities. We can tailor the audits based on your needs. Remote audits are allowed
Our experts can help you maintain your internal audit QMS requirements.
We can also support specific areas focused on:
- 60601-1 (Medical Electrical Equipment),
- Risk Management,
- Technical Documentation (MDR),
- Design History Files,
- Gap Assessments, etc.
Also, see our blog post on remote audits to learn What You Need to Know About for Remote Audits.
Feel free to contact us to discuss your needs. Schedule a call with Leo to help you thru this process.