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Who is CriTech?

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Why use CriTech?

Certification and Compliance

Certification and Compliance

Verification and Validation

Software Development

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CriTech Research has many years of experience with outsourcing software projects. We have considerable expertise in the development of software applications. We can bring to bear a large number of developers to work on a project at any given time.

The combination results in a dramatic reduction in the time needed to deploy your new product. Our experience can save considerable development cost.

Within the medical device industry, the medical device manufacturer must ensure that all software is developed in compliance with all applicable regulations and standards.

Consider:

FDA Quality System Regulation

Medical Device Directives (MDD)

21 CFR Part 11

IEEE Standards for Software Development

IEC 62304, Medical device software -- Software life cycle processes

ISO 12207


CriTech Research's standard practices and procedures fully comply with all of these regulations and standards.

Benefits of Outsourcing

Outsourcing can save time:

Reuse

Staffing flexibility

Experience

Better requirements specification

Reduced feature creep


Outsourcing can provide reduced manpower fluctuations:

Outsourcing helps eliminate the need to staff up internally for a rush project

 

Keys to Success in Outsourcing

Here are some keys to success in Outsourcing:

Select the vendor with care

Craft the contract with the vendor carefully

Make communication with the vendor a priority, both electronically and in person

Give special consideration to outsourcing the reengineering of legacy-systems (retrospective)

 

Considerations with Outsourcing

When preparing to outsource, CriTech recommends that you:

Develop a management plan, including risk management

Make communication with us a priority

Be leery of unstable requirements

Especially consider outsourcing legacy-systems reengineering

Avoid double standards for outsourced work

 

CriTech Helps Manage Outsourcing

Three key factors must be addressed for successful outsourcing development:

Ensure visibility
Our status reports provide timely and meaningful visibility into the current status of development, allowing you to monitor and assess our progress.

Minimize loss
At the end of the project, we provide training and consulting to ensure a successful transition of the developed work products into your organization.

Protection of confidential information
Our contractual practices ensure that proprietary data and algorithms are properly identified and are carefully protected.

 

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Last modified: August 2009