|
Home
Up
Quality Systems
Recalls
Design Control
Clinical Trials
MDR-Vigilance
Promotion
Electronic Signature
| |
Compliance Services
Our broad range of compliance services are designed to help small and medium
sized companies maintain compliance with the
ever-increasing quantity and authority of regulatory agencies'
requirements while exercising cost control through the
elimination of redundancies and streamlining overcompliance.
- Quality Systems
- Whether you are starting up a new company, preparing for ISO 9000
or 13485/8 certification or FDA
inspection, or attempting to bring a costly, overcompliant certified quality system in
line with budget, The CRO Group consultants have worked for
both leading
Registrars/Notified Bodies and medical device manufacturers,
and are uniquely
qualified to provide a solution tailored to your company, easy to implement, and
not
requiring excessive overhead to maintain.
- Clinical Investigations
- As a result of changes to the 21CFR812 regulation (Investigational Device Exemption) as
well as harmonized guidance documents, compliance is expected to be demonstrated by
monitoring or audit. The CRO Group are specialists at conducting these audits, or
setting you up to do it yourself.
- MDR- EU Vigilance
(MDV) -Canadian (AER)
- The CRO Group can help you
set up your MDR (Medical Device Reporting) system for reporting adverse events
in compliance with 21 CFR 803, as well as expand
your MDR system so that it complies with the EU Vigilance
(MDV) and the Canadian AER (Adverse Event Reporting) requirements. whether you currently do this manually, with a purchased
software program, or a "home brewed" one.
- Advertising & Promotion
- FDA has historically treated company Internet websites
as advertising and considers advertising to be regulated under 21 CFR 801 and
807. Many companies which have made additional product claims (ex. heals
wounds in minutes, genetically detects pneumonia) not within their FDA product
submission have received warning letters charging misbranding of
products due to false or misleading information.
The CRO Group can help you keep your website in compliance with FDA's policy
on advertising and promotion. If you're starting from scratch, The CRO
Group can develop and implement a website that complies with FDA policy and
may even improve your international marketing efforts
- Electronic
Signature/Records
- The FDA with little advance warning, rescinded the many
guidances and declared that several of the most difficult requirements of Part
11, including the generation of unalterable audit trails was being placed on a
discretionary exemption for legacy systems (prior to the issuance of the
regulation) and where the regulated company relied and maintained a paper
record which could be relied upon for compliance with another regulation..
The CRO Group can perform gap analysis and remediation services to get your
electronic systems into compliance.
- US Agent / EU Authorized
Representative
- The CRO Group is registered as a US Agent for foreign
medical device manufacturers. We also maintain an office in Europe to
act as your Authorized Representative which is a requirement for all medical
and IVD CE Marked devices.
-
- To receive more information, or have a salesperson
contact you, please fill out the form below. For faster service,
including a no-obligation quotation, please click here.
|