Save Time and Cost
You can create a medical device SOP for your Quality System the quick inexpensive way or the slow expensive way.
The quick inexpensive way is to base your system on generic medical device SOP's and tailor as needed. The slow expensive way is to custom-write each medical device SOP. A recent industry-wide survey by Pathwise, a large consulting and training firm, showed that the majority of respondents take 3-5 days to write,edit, and rewrite a SOP and to create forms. Our SOP's are in Word format for easy editing. The SOP will be complete and ready for use. They are not templates where you fill in the blanks.
Custom written SOP forms especially run the risk of necessary information being omitted. Our time tested SOP forms assure that all necessary information is entered by personnel. These SOP forms will be FDA audit-ready.
Medical device designers would not custom design a component when they could buy a time tested off the shelf component (eg. valve). Software Engineers would not develop custom medical device software when OTS programs are available. Why then custom write a medical device SOP? The procedure for conducting hazard analysis, for example, will not differ from company to company. Why reinvent the wheel? Spend your valuable time on your project, not on writing procedures.
Our SOP's are maintained to be up to the minute in reflecting latest FDA thinking. Subjects of the SOP's are not only complex but are a moving target due to frequently issued Guidances. For example, do you know when Human Factors Validation testing is required? The criteria has been recently clarified. Do you know how many participants in a validation test are required? Our Human Factors SOP explains all.
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When you buy a SOP group you get 2 hours of free consulting time to help you implement the SOP's.
Med Device Advisors provided medical device SOP's to a startup founded by 2 Gastroenterologists with a new product idea. They used these SOP's with Med Device Advisors guidance to establish their Quality System (reference upon request).
To help you understand the SOP's and how to best implement them, a Powerpoint presentation (40-50 slides) will be included at no charge with each SOP group purchase. The slides will explain the subject matter related to the SOP's. Included will be real life examples. Between the slides and the SOP you will understand the context of the medical device regulations as well as the regulations.
These Powerpoint slides are professionally prepared and currently used in medical device webinar and seminar presentations. These slides could be used for training purposes.
SOP's are available individually on this website or in combination with webinars on medical device subjects on the Online Compliance Panel website: www.onlinecompliancepanel.com.
FDA/ ISO Compliant Device Development Program
By combining the Design Control and Risk Management SOP Groups you will have a product development program that will meet FDA 21CFR820.30 and ISO13485.
FDA/ ISO Compliant CAPA Program
Our CAPA SOP group establishs a CAPA program that will meet FDA 21 CFR requirements including new MDR requirements
FDA Compliant Human Factors/ Usability Program
Our Human Factors/ Usability SOP group will establish a Usability program that will meet FDA and ISO 62366 requirements including the complex requirements for Human Factors validation following the new FDA and ISO Guidances
We have been supplying medical device SOP's to the medical device industry for over 10 years.SOP's have been purchased by companies ranging from startups to giants like Sanofi-Aventis, Canon Medical Systems and Dow Pharma. (Click on "SOP's Available"). SOP's are in Word format. Forms are in Excel format.
Custom SOP's run the risk of either being too brief to be an effective procedure or too long . There may be several possible interpretations of a too-brief procedure. A procedure that is too long and detailed may be ignored because of its complexity and difficulty to quickly understand. There is always the danger of personnel who "know" what to do and will not refer to an overly long SOP.
TO AQUAINT YOU WITH THE VALUE OF THESE MEDICAL DEVICE SOP'S A SOP WILL BE SENT TO YOU FREE.
Choose any SOP. Enter the SOP name or number and "INTRODUCTORY OFFER" in an email to firstname.lastname@example.org. The SOP will be emailed to you.
For answers to FAQ's about SOP's go to the Pilgrim Software blog on their website: http://blog.pilgrimsoftware.com/wordpress/?p=435 . Medical Device SOP Advisors was interviewed and provided the answers.
Superior SOP Content
Our SOP's are superior to custom company written documents because they incorporate years of experience in directly dealing with the FDA. Medical Device SOP Advisors is led by a Lloyds of London Certified ISO 9000 Lead Auditor who is also a member of Thomson Reuters Medical Device Expert Witness Network. He is a former Engineering and Manufacturing manager who is now an internationally recognized Regulatory consultant. In addition to consulting he presents many webinars on medical device subjects. Practical cost effective approaches to meeting FDA SOP requirements were created.
Why risk 483's by writing your own medical device SOP's? The FDA continuously increases it's Quality System expectations. Recently changed requirements are: risk-based analysis, postmarket product problem analysis, and Human Factors/ usability analysis. Did you know that an acceptable Validation now includes actual user testing in the use environment of primary and safety related functions? Do you know how many test users are necessary? Unfortunately, these changes are not publicized. Examples of changes to our SOP's in recent years are:
• CAPA procedures include latest FDA postmarket requirements
• FDA recommended ISO and IEC procedures are incorporated into the SOP’s, such as ISO 13485 and ISO 14971 in the Risk Analysis SOP and ISO 62366 in the Human Factors SOP
• Latest FDA guidance documents are incorporated into the SOP’s
• Risk analysis SOP includes human factors and the latest FDA thinking on medical device use error
• Design Control SOP’s include risk based analysis
Who can keep up with these unpublicized changes? Medical Device SOP Advisors can and does. Purchase our audit-ready SOP's and be assured that your company will meet the latest FDA medical device requirements.
3-SOP's are complete and compliant with the latest FDA thinking
4-forms are complete and call for all necessary information
5-free consulting time is included to help with the implementation of the medical device SOP
Our medical device SOP's are sufficiently detailed so that they may be used as training documents, saving the time and cost of preparing training material.
Consulting services to customize and support these medical device SOP’s and their implementation are offered.(click on "Services")