We maintain constant surveillance over the rapidly changing U.S. regulatory policies from the Food and Drug Administration (FDA) and monitor international trends.

OTech Inc. has assisted many companies in bringing their PACS devices to market and has a proven track record (references available on request).

1. Determine what classification your device falls under so that the appropriate rules for filing etc. can be applied.
2. Prepare and Submit All Regulatory Filings - 510(k) Pre-market Notifications, Site Registration, Device Listing, and Medical Device Reporting.
3. Provide a "510(k)Survival Kit" for PACS which contains a 510(k) filing template, both in hard as well as softcopy, and all the appropriate supporting documentation and forms that are needed. This template has helped many companies to submit successfully 510(k)s to the FDA on their own.
4. 510(k) Pre-market Notification Audits - Our staff can review and audit your PACS 510(k) submission(s) before they are sent to the FDA. Seasoned professionals in PACS, with proven track records, will report on potential problems or areas that could delay FDA clearance, which could cost you thousands of dollars in lost revenue.
5. Follow Up - We will handle any and all post 510(k) submission questions from the FDA.
6. Training - Comprehensive training in specific or general regulatory topics which can be customized to serve your individual needs.

The agent will assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment.

OTech will function as an US agent, as defined and required by the FDA final rule.

The agent will:

• Assist the FDA in communications with the foreign establishment
• Respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States
• Assist FDA in scheduling inspections of the foreign establishment.
• If the FDA is unable to contact the foreign establishment directly or expeditiously, the agent will facilitate information or document exchange between the FDA and the foreign establishment.
• The agent will file either the Initial Registration Device Establishment Form 2891 (if you have previously never registered with FDA) or file the Annual Registration of Device Establishment Form 2891(a).

• When and how do you file a 510(k)? When does a design change warrants a new 510(k)? How are ISO 9000; ISO 9000:2000 and the FDA Good Manufacturing Regulations similar?
• What you need to do for medical device software verification/validation compliance? How do you implement the new FDA design controls?

• Quality System - We can assist you with implementing a complete quality system meeting the FDA QSR requirements ranging from the Quality manual to all the individual operating procedures, customized to your specific needs and requirements.
• Audits - A complete or specific review of facilities, work, material flow, software, testing, and documentation.
• Standard Operating Procedures - We review and/or develop the required FDA operating procedures to meet regulatory compliance.
• Manufacturing - Hardware & Software validation methods.