Regulatory Compliance
Certain classes of medical imaging devices that are sold or manufactured in the USA must be auditable for full compliance to the FDA’s Code of Federal Regulations and, under certain conditions, ISO-9001 Quality Process (guidance). International sales or importation of such devices may require additional approvals & labels, such as a CE mark.
Note: compliance advice provided here is not legally
binding in any way; eMail Don Shave for details.
21CFR-820
TITLE 21--FOOD AND DRUGS
CHAPTER I--FDA, DHSS
SUBCHAPTER H--MEDICAL DEVICES
PART 820 QUALITY SYSTEM REGULATION
Subpart A--General Provisions
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
Subpart B--Quality System Requirements
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
Subpart C--Design Controls
§ 820.30 - Design controls.
Subpart D--Document Controls
§ 820.40 - Document controls.
Subpart E--Purchasing Controls
§ 820.50 - Purchasing controls.
Subpart F--Identification and Traceability
§ 820.60 - Identification.
§ 820.65 - Traceability.
Subpart G--Production and Process Controls
§ 820.70 - Production and process controls.
§ 820.72 - Inspection, measuring, and test equipment.
§ 820.75 - Process validation.
Subpart H--Acceptance Activities
§ 820.80 - Receiving, in-process, and finished device acceptance.
§ 820.86 - Acceptance status.
Subpart I--Nonconforming Product
§ 820.90 - Nonconforming product.
Subpart J--Corrective and Preventive Action
Subpart K--Labeling and Packaging Control
§ 820.120 - Device labeling.
§ 820.130 - Device packaging.
Subpart L--Handling, Storage, Distribution, and Installation
§ 820.140 - Handling.
§ 820.150 - Storage.
§ 820.160 - Distribution.
§ 820.170 - Installation.
Subpart M--Records
§ 820.180 - General requirements.
§ 820.181 - Device master record.
§ 820.184 - Device history record.
§ 820.186 - Quality system record.
§ 820.198 - Complaint files.
Subpart N--Servicing
§ 820.200 - Servicing.
Subpart O--Statistical Techniques
§ 820.250 - Statistical techniques
FDA provides complete details of 21CFR Part 820 here, a video summary of the FDA's rules here and many, many other learning items here. Other relevant compliance rules include exportation which may be viewed here, imports which are here, privacy of patient data which is here, software validation which is here, CAPA which is here, and critical data about submssions for a 510(k) here.
QMS
A complete Quality Management System (QMS) is required to both achieve and to maintain full compliance for medical imaging device manufacturers, and is by nature extremely broad in scope.
Such a QMS must be controlled and auditable to demonstrate compliance (download a printable copy of FDA's Quality System Inspectional Technique), as well as coverage from "womb to tomb" for product development -- here is a generalized example of a Quality Manual which would support a QMS.
A summary viewpoint of a QMS is described on a web page that I built several years ago:
http://my.execpc.com/~shaved/definitions.html#Regulatory
ISO compliance is the 1st step towards achieving compliance with European regulatory requirements; conformity to EEC rules must be assessed and a CE certificate applied before sales are allowed. C
ertification of the QMS by a conformity assessment body solves this.
ISO9001 & ISO13485 are virtually identical:
http://en.wikipedia.org/wiki/ISO_13485 A comparison is made here of FDA vs ISO...
http://elsmar.com/Forums/showthread.php?t=6160
