ISO 13485, ISO 9001, Regulatory Submissions IDE, 510k, PMA, Clinical Trials International, FDA Help, Consulting & Quality System Requirements

Experts In:

	Regulatory Affairs
	Quality Systems and Compliance
	Venture Capital Due Diligence
	Clinical Trial Design & Management
	Database Development & Compliance


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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
	Performing Due Diligence Audits

QSR/CGMP Compliance Support
	Conducting in-house training for QSR and ISO

Compliance and Computer Validation

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 Stuff
Methodize Inc's key capabilities include: pre-market assessment, protocol reviews, statistical strategies, sample size calculation, regulatory applications, IDE, 510(k) and 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.

We understand the importance of getting a product to market as quickly as possible — without regulatory missteps that can cost thousands or millions of dollars in lost sales later on. Toward this end, we offer:

Application and Submission Services

	Assistance with Regulatory Strategies and Assessment
	Preparation of FDA Registration and Listing, US Agent for FDA Requirements
	Liaison with FDA for Pre-submission or Special Meetings
	Assistance with FDA's GCP Requirements for Sponsors, Monitors, and Clinical Investigators
	GCP Audits/Monitoring and Data Integrity Audits
	Statistical Reports
	Guidance in Development of Briefing Package for FDA Meeting
	510(k), IDE, PMA Preparation and/or Assistance
	Preparation and/or Assistance with Submission Amendments and Supplements as well as Required Reporting Records
	Development of Strategies for Advisory Committee Meetings
	Assistance in CE Mark Submission

Please contact us to discuss how we can help you