21 CFR Part 820 Subpart N – Servicing

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Description:

As servicing is not required of all medical devices, this subpart of the regulations is one of the more commonly excluded regulations from an organization’s quality system requirements. That being said, we will discuss reliability testing in this module, which is quite useful for other areas of medical devices, beyond just that of servicing and is worth the time to review. If service is required processes need to be established on how systems will be serviced and maintained. A good ‘rule of thumb’ is that if service is going to be needed or provided for the product, traceability should be maintained via a serial number (versus a lot number).

Curriculum for this course:

Introduction

Overview	1 mins 10 secs
ISO, ICH and the FDA	1 min 30 secs
Program organization	1 min 25 secs
Program objectives	1 min 50 secs
Definition of a medical device	1 mins 11 secs
Class I, II and III	1 mins 33 secs
Intended use	1 mins 10 secs

History of 21 CFR Part 820

21 CFR 820 Timeline	1 min 50 secs
1906 – The Jungle	1 min 45 secs
1937 – Massengil Company	1 min 10 secs
1957 – Thalidomide	58 secs
1971 – Dalcon Corporation	1 min 48 secs
1990 – FDA device recall report	1 min 24 secs
A regulatory evolution	1 min 30 secs

Servicing – Subpart N

Course Introduction	1 min 12 secs
Learning Objectives	1 min 42 secs
Servicing	1 min 02 secs
Reliability Testing	1 min 24 secs
Reliability Testing – Probability	1 min 32 secs
Reliability Testing – Samples	1 min 12 secs
Service Records	58 secs
Service Records – Customer Information	1 min 43 secs
Service Records – Installation	1 min 30 secs