Medical Device SOP Advisors can customize these procedures for your company. Send us an email using the Contact Form and a representative will call you to discuss your needs. Based on our many years of experience, customization typically involves no more than 1-3 hours of work per SOP.
SUPPORT FOR SOP’s AND THEIR APPLICATION
An option is to purchase several hours of application support time. Questions concerning the application of these SOP’s may be submitted by telephone or email. Email questions will be answered within 2 business days. Support time will be tracked and credited against time purchased. Time is billed at $75 per hour. Send us an email using the Contact Form including credit card information and the desired hours. Purchased time never expires.
TRAINING ON THE USE OF SOP’S
Medical Device SOP Advisors can conduct training for your staff on the purchased SOP’s at your site. FDA requires that employees that use SOP’s are trained and understand the SOP’s. A Power point presentation plus handouts will be used. Ample Q &A time is included. We can also train your Quality staff in practical audit procedure based on years of experience in FDA audits. Send us an email using the Contact Form and a representative will call you to discuss your needs.
Medical Device SOP Advisors will consult on any medical device FDA GMP/ QSR or ISO issues. The Consultant will be a Lloyds of London Certified Lead Auditor.