Methodize Inc - ISO 13485, ISO 9001 Consulting & Certification
Experts In:
Regulatory Affairs
Quality Systems and
Compliance
Venture Capital Due Diligence
Clinical Trial Design &
Management
Database Development & Compliance
EU Authorized Representative
Investigational Device Exemption
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Methodize Inc. Blog
Contact Person:
Jack Slovick

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info@methodizeinc.com
 

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Methodize Inc. is a consulting and training firm specializing in regulatory, clinical and quality services.

Jack Slovick: President

Welcome to Methodize Inc.

CE Marking Consulting, ISO 13485 & ISO 9001 Certification, Clinical Trials US, EU & International, Authorized European Representative

Methodize Mission: Our mission is to provide our clients knowledge, integrity and services to successfully take their products from an idea
on a napkin to market.

Meet Methodize Inc. at the MEDICA 2009
Medical Forum and Trade Fair in Dusseldorf, Germany
November 18-21, 2009.

Visit us at the USA CEO Center in Hall 16, C 04.


Please
contact us to discuss how we can help you.
 
Our Services
With over 35 years of combined Regulatory, Quality and Clinical services we have been helping companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market. Anyone can read the regulations, we provide efficient and effective solutions. Our services also ensure that post market compliance is maintained through labeling advice and compliance with the applicable regulations. Whether you are pondering the most effective way of pursuing a regulatory submission, starting up a clinical trial or need to meet a quality system regulation or international standard, Methodize is the one to call.
Audits
Conducting In-house and Vendor QSR/ ISO 13485/ ISO 9001:2000 Audits
Conducting Mock FDA Inspections
Conducting ISO Audits
QSR/CGMP Compliance Support
Assisting in Developing Design Controls and Validation Requirements
Assisting in Developing Quality System Requirements
Resolve QSR/CGMP Problems

Regulatory / Clinical Support

Methodize Inc's key capabilities include: pre-market assessment,  protocol reviews, statistical strategies, sample size calculation, regulatory applications, IDE, 510(k) andre PMA support, investigational site monitoring, data entry, statistical analysis, data management, final reports, investigational site audits, sponsor audits, medical device clinical research training in good clinical practices (GCP), clinical trials design, project management for clinical studies and more.

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