Documents

The CRO Group offers its clients a standards and regulations update service. Each month, based on your industry sector and product characteristics, The CRO Group on line document spider crawls over the Internet identifying newly released documents and notifies you of those which may apply to your business. Notification may either be via fax, email, or express mail. Those documents which are not copyright protected such as regulations and directives we offer directly to you. For copyright protected documents we list how you can acquire a copy. For more information about this service, please click here.

Have you ever been away from your desk, and you needed to look up a requirement of a regulation?

Now, with The CRO Group's new service, P.D.A. Regs, if you have a PDA (Personal Digital Assistant), the regulations are a few buttons away. We currently offer USA/FDA, EU, and Canadian regulations for the medical device industry. Perfect for the QA Manager and Auditors, P.D.A. Regs brings you the following documents and many more and allows a PDA with Adobe® Acrobat® Reader® (free download for PalmOS® click here) to view regulations, search on specific terms such as "validation" and "software" and leaves the user in total immediate command of the requirements of interest. Each item is a flat charge of $19.95, and may be charged to Mastercard, Visa, or American Express. For more information about this service, or an immediate purchase, please email us: stdsradar@crogroup.com.

Document	Applies to	Document Title
21 CFR 7	Medical Devices, Pharmaceuticals	Recalls
21 CFR 11	CROs, Biologics, Medical Device, IVD, Pharma Manufacturers	Electronic Signature, Electronic Records
21 CFR 21	CROs, Biologics, Medical Device, IVD, Pharma Manufacturers	Protection of Privacy
21 CFR 56	CROs, IRBs	Institutional Review Board
21 CFR 58	CROs, Biologics, Medical Device, IVD, Pharma Manufacturers	Good Laboratory Practices
21 CFR 801	Biologics, Medical Device, IVD, Pharma Manufacturers	Labeling
21 CFR 803	Medical Device, IVD, Manufacturers	Medical Device Reporting
21 CFR 807	Medical Device Manufacturers	Establishment Registration and Device Listing
21 CFR 809	IVD Manufacturers	IVD Products for Human Use
21 CFR 812	Medical Device, IVD Manufacturers	Investigational Device Exemption
21 CFR 820	Medical Device, IVD Manufacturers	Quality System Regulation
CD 93/42/EEC	Medical Device Manufacturers, Notified Bodies	EU Medical Devices Directive
CD 98/79/EC	IVD Manufacturers, Notified Bodies	EU IVD Directive
CD 2004/9/EC	Manufacturers conducting CE Mark Testing, Test Laboratories	GLP Inspections
CD 2004/23/EC	Biotech manufacturers, Human Tissue/Cell manufacturers, Medical Device manufacturers utilising human tissue	Quality and Safety of Human Tissue and Cells
PC 1998-783	Medical Device, IVD Manufacturers, CMDCAS Registrars	Canadian Medical Device Regulations
GD-210	Medical Device, IVD Manufacturers, CMDCAS Registrars	ISO 13485 Audits performed by CMDCAS Registrars Guidance

Don't wait for an auditor or inspector to tell you your standards are obsolete

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