PRIVACY POLICY
This privacy policy sets out how TABS uses and protects any information that you give TABS when you use this website. TABS is committed to ensuring that your privacy is protected. Should we ask you to provide certain information by which you can be identified when using this website, then you can be assured that it will only be used in accordance with this privacy statement. TABS may change this policy from time to time by updating this page. You should check this page from time to time to ensure that you are happy with any changes. This policy is effective from 18th of February, 2012.
What we collect
We may collect the following information:
- name and job title
- contact information including email address
- demographic information such as postcode, preferences and interests
- other information relevant to customer surveys and/or offers
What we do with the information we gather
We require this information to understand your needs and provide you with a better service, and in particular for the following reasons:
- Internal record keeping
- We may use the information to improve our products and services
- We may periodically send promotional emails about new products, special offers or other information which we think you may find interesting using the email address which you have provided
- From time to time, we may also use your information to contact you for market research purposes
- We may contact you by email, phone, fax or mail
- We may use the information to customise the website according to your interests
Security
We are committed to ensuring that your information is secure. In order to prevent unauthorised access or disclosure we have put in place suitable physical, electronic and managerial procedures to safeguard and secure the information we collect online.
How we use cookies
A cookie is a small file which asks permission to be placed on your computer's hard drive. Once you agree, the file is added and the cookie helps analyse web traffic or lets you know when you visit a particular site. Cookies allow web applications to respond to you as an individual. The web application can tailor its operations to your needs, likes and dislikes by gathering and remembering information about your preferences. We use traffic log cookies to identify which pages are being used. This helps us analyse data about webpage traffic and improve our website in order to tailor it to customer needs. We only use this information for statistical analysis purposes and then the data is removed from the system. Overall, cookies help us provide you with a better website, by enabling us to monitor which pages you find useful and which you do not. A cookie in no way gives us access to your computer or any information about you, other than the data you choose to share with us.You can choose to accept or decline cookies. Most web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. This may prevent you from taking full advantage of the website.
Links to other websites
Our website may contain links to other websites of interest. However, once you have used these links to leave our site, you should note that we do not have any control over that other website. Therefore, we cannot be responsible for the protection and privacy of any information which you provide whilst visiting such sites and such sites are not governed by this privacy statement. You should exercise caution and look at the privacy statement applicable to the website in question.
Controlling your personal information
You may choose to restrict the collection or use of your personal information in the following ways:
- Whenever you are asked to fill in a form on the website, look for the box that you can click to indicate that you do not want the information to be used by anybody for direct marketing purposes. If you have previously agreed to us using your personal information for direct marketing purposes, you may change your mind at any time by writing to us.
- We will not sell, distribute or lease your personal information to third parties unless we have your permission or are required by law to do so.
- We may use your personal information to send you promotional information about third parties which we think you may find interesting if you tell us that you wish this to happen.
- You may request details of personal information which we hold about you under the Data Protection Act 1998. A small fee will be payable. If you would like a copy of the information held on you please contact us.
- If you believe that any information we are holding on you is incorrect or incomplete, please write to or email us as soon as possible, at the above address. We will promptly correct any information found to be incorrect.
M. Joyce Heinrich
12101 Cullen blvd. Suite A
Houston, Texas 77047
Phone: 713-734-4433
E-Mail: Tabsii2@comcast.net
Authorized US Agent
Registered with the FDA as an Authorized US Agent and for medical device establishments located outside of the United States. The FDA issued a regulation that became effective February 2002 requiring non-U.S. medical device establishments that market their products in the United States to register their companies and identify a US Agent as their official correspondent.
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
TABS IRB: IORG0007231
- Monthly Meetings
- Three day delivery services of approved documents to researcher or investigator
- Same day expedited approval for items allowed under FDA regulations
- One month notification of Progress Reports due sent to researcher, investigator and sponsor
- RRC forms, instructions, sample documents available on diskette using MS Word for Windows or WordPerfect
- One time review fee per study protocol
- Discount for Multi-Center Studies
- Instruction Booklets for researcher, investigator and sponsor
- In-Service Training Programs
- Product Design Review
- Protocol Development
- Clinical Monitoring for research and clinical studies
- Development of Software Programs for data analysis
- Statistical Analysis
Authorized US Agent
Registered with the FDA as an Authorized US Agent and for medical device establishments located outside of the United States. The FDA issued a regulation that became effective February 2002 requiring non-U.S. medical device establishments that market their products in the United States to register their companies and identify a US Agent as their official correspondent.
Specialist with 50 plus years experience!
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We offer other services encompassing several disciplines which when utilized will assist you in achieving your goals and improving your P&L. TABS provides a full range of Clinical Investigation/Study Services for the Medical Device Industry.
Let Us Keep Tabs For You.
Authorized US Agent
Registered with the FDA as an Authorized US Agent and for medical device establishments located outside of the United States. The FDA issued a regulation that became effective February 2002 requiring non-U.S. medical device establishments that market their products in the United States to register their companies and identify a US Agent as their official correspondent.
CLINICAL TRIALS
TABS provides a full range of Clinical Investigation/Study Services for the Medical Device Industry. With TABS expertise, we can assist in the design of your clinical study from Protocol Development, selection of Clinical Investigators, Training, Monitoring and Total Management of the study with Database Design, Implementation and On-Going Progress and Final Review and Reporting to ensure Regulatory Compliance with GCP and GLP.
- Product Development
- Quality Audit
- Monitoring
- Data Analysis
- Clinical Monitoring
GENERAL
- Training Programs
- Establishment Registration
- Clinical Trials (IDE/IND)
- Institutional Review Board
COMPLIANCE
- QSR & GLP
- QA / QC
- Audits / Inspections
- ISO 9000 & CE Mark
RESEARCH & DEVELOPMENT
- Product Development
- Design Review
- Design Validation
- Computer Aided Design
REGULATORY
- US Agent
- Official Correspondent
- FDA Submissions (IDE/PMA/510k)
- Warning Letters
- Recall Response
- Regulatory Strategies
Strategic Planning is paramount for any company in the development of New Technologies and Medical Devices. TABS provides a full range of Regulatory Expertise to assist and support Medical Device Companies to ensure Regulatory Compliance for each stage of Product Development through Market Release and beyond.
- Preparation of FDA Registration and Device Listing
- Preparation of Premarket Notification Submissions
- Product Development Protocol (PDP)
- Investigational Device Exemption (IDE)
- Premarket Approval Application (PMAA)
- 510(k) Notification
- Liaison with FDA for Regulatory Actions, Warning Letters, Recall Response and MDR Reports
- Warning Letters
- QSR Inspection Deficiency Notices (FDA Form FD-483) Response
- Assessment of Recall Strategy
- Assessment of Medical Device Reporting Strategy and Report
Strategic Planning is paramount for any company in the development of New Technologies and Medical Devices. TABS provides a full range of Regulatory Expertise to assist and support Medical Device Companies to ensure Regulatory Compliance for each stage of Product Development through Market Release and beyond.
- Preparation of FDA Registration and Device Listing
- Preparation of Premarket Notification Submissions
- Product Development Protocol (PDP)
- Investigational Device Exemption (IDE)
- Premarket Approval Application (PMAA)
- 510(k) Notification
- Liaison with FDA for Regulatory Actions, Warning Letters, Recall Response and MDR Reports
- Warning Letters
- QSR Inspection Deficiency Notices (FDA Form FD-483) Response
- Assessment of Recall Strategy
- Assessment of Medical Device Reporting Strategy and Report