TEKFILE Services can provide a full range of support from validation protocols to establishing all of the documentation to meet the guidelines for ISO 13485, FDA GLP and cGMP compliance. We can write all the SOPs for manufacturing, O.C.., facilities, etc. We will identify guidelines for testing the products based on FDA accepted procedures. We can help to establish the "Quality" System throughout a facility in the following areas:

	Quality System Implementation, ISO 13485, TQM, CMDR
	Writing documentation – standard operating procedures, standard testing procedures, standard manufacturing procedures, quality manuals, training manuals,; NCCLS format, when required
	Raw material testing and control
	Risk Management & FMEA for Medical Devices
	Equipment and facilities validation protocols
	Process validation
	Quality Control procedures and release criteria generation
	Customer complaint handling and recall procedures
	Quality Systems Manual
	Labeling and quarantine SOPs
	Design validation and verification
	Guidance for Developing Inspection and Test Criteria
	Identification and Traceability in Medical Device Tracking
	Audit guidelines, checklists, procedures and Training
	Design Control
	Strategic Supplier Partnership Programs
	Verification and Validation Activities
	Stability Studies for In vitro Diagnostic Devices
	CE Mark
	Calibration
	CAPA System
	Sensitivity and Specificity
	510(k) Document Creation

As a regulatory consulting organization, it is our responsibility to stay abreast of the FDA requirements for medical device manufacturers, which change regularly. Our long time experience with the FDA regulations include 510(k), PMA, IND and PLA submissions.


510(k) Submissions

We have successfully prepared 510(k) submissions for over eighty devices that range from Scimedx Primate Umbilical Cord (EMA/PUC) IFA Test for detecting Anti-Endomysial IgA Antibody in human serum to . EIA Kit for the Detection of GBM Antibodies and much more.

We offer support for the preparation of the entire submission package or we can focus on specific needs for validation documents. Our regulatory submissions support services address the requirements of the FDA and CE Mark. We offer solutions resulting from our extensive experience on the most effectively structured submission aimed at minimizing questions and streamlining the review process. Examples of our work include:

510(k) for diagnostic device: Developed strategy that resulted in reducing the submission schedule by three months from company schedule and competitor bid.

Clinical trials: Designed clinical trial plan that reduced the number of sites, number of patients, and facilitated the validation and analysis of collected data. Significant savings realized in schedule and cost.
We can ensure the success of your next 510(k) and shorten the cycle time required to prepare your submission documents.