ADVERTISEMENT
Home
Research Center
News
Company Index
Login or
Become a Member!
Forgot password?
Medical Device Directory
ISO Compliance
by
MDI Consultants Inc.
ISO is a set of global quality standards that are geared to companies providing products or services as a framework for achieving customer satisfaction through implementing a quality management system. The ISO set of standards have become an important mechanism to allow companies to inform their customers and competitors that they have implemented an externally-accepted quality system in addition to enabling companies to increase conformity and efficiency in their operations. ISO is continually increasing its global presence and becoming a regulatory requirement for many industries.
mdi Consultants has assisted over 150 companies achieve ISO compliance across a wide array of ISO standards (e.g. ISO 9001:1994, ISO 9001:2000, ISO 13485 (EN 46001), ISO 13488 (EN46002)). We have guided many companies across the following industries: medical device, pharmaceutical, clinical research organizations (CRO), food and other manufacturing (e.g. parachute manufacturer, aerospace, defense). Our customer testimonials will provide you a glimpse of the experience of working with mdi on ISO. In addition, mdi guarantees, if you follow our program, you will achieve ISO compliance on your first audit by a certifying registrar.
Visit WebSite
View MDI Consultants Inc. profile
Available from MDI Consultants Inc.
Click image to enlarge
More Products from MDI Consultants Inc.
Mock FDA audit for foreign companies via SKYPE
Available from:
MDI Consultants Inc.
Foreign companies should be prepared for FDA inspections of the operations. Having a consultant on site with extensive FDA experience is the best way to go. The second best way to be prepared for an...
Read More
FDA Compliance for Medical Devices Companies
Available from:
MDI Consultants Inc.
Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. As professional consultants to the healthcare industry for over 2...
Read More
Crisis Intervention
Available from:
MDI Consultants Inc.
Are YOU presently concerned or involved in any of the following?
Recently received a notice of a forthcoming FDA audit
Received an FDA Warning Letter
Received non-conforming...
Read More
CE Mark / MDD / IVDD / AIMDD
Available from:
MDI Consultants Inc.
CE Mark is the European Community requirement for selling devices within Europe. This means that without the CE Mark you cannot sell your medical device within the European Community. The CE Mark...
Read More
In Vitro Diagnostic R&D
Available from:
MDI Consultants Inc.
mdi Consultants, Inc. has helped many In-Vitro Diagnostic Device companies through a number of difficult research and development problems and issues. Can you respond “yes” to any of the following...
Read More
HACCP Consulting Services
Available from:
MDI Consultants Inc.
HACCP is a tool that was originally developed for the seafood industry to determine potential hazards in your production process that might critically effect the quality of your end products. At the...
Read More
Business Development Consulting
Available from:
MDI Consultants Inc.
Mdi Consultants offers a new full turn key business development solution to medical device manufacturers who need and seek to have business development meeting opportunities facilitated at the...
Read More
Reimbursement Consulting
Available from:
MDI Consultants Inc.
Current Procedural Terminology (CPT Codes) and ICD-9 Codes
Level I Codes (Current Procedural Terminology)are medical services and procedures codes used by physicians filing for payment for...
Read More
Clinical Trial Management
Available from:
MDI Consultants Inc.
Our services include developing the clinical protocol, setting up and interacting with the IRB (Institutional Review Board), submitting the IDE (Investigational Device Exception), recruiting and...
Read More
Premarket Notification Preparation 510(k)/PMA
Available from:
MDI Consultants Inc.
Prepare 510(k)s for new devices planned for market and submit amended 510(k)s for changes in devices already being distributed.
Obtaining FDA interpretation on device problems while...
Read More
ISO Compliance
ADVERTISEMENT