Role of 13485 Consultants

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• The major role of consultants explained below. Customers have the option of choosing any of the option along based on your requirement, but normally we advice our clients to utilize our services completely

I.  Define Scope and Process Mapping
II.  Review of adherences towards regulatory compliances
III.  Training
Our Onsite consultancy starts with awareness training to all followed by training to MR and assistant MR. Internal auditor training will be provided before first Internal Audit.
Clients have the choice of utilizing our service for training along.
Please refer the fee structure
IV.  Implementation
V.  Internal Audit
We schedule our internal audit program to reach almost all activities as part of our ISO 13485/CFR 820 consultancy which in turn helps organization to face Notified Body /US FDA audit with much courage
Clients have the choice of utilizing our service for Technical consultancy, Training, Internal audit and Gap analysis.
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Advantages by appointing us

• Qualified and experienced consultants
• ISO 13485 Certified Lead Auditors
• Largest customer base
• Largest reference standard and document collection
• Offsite (online) consultancy with very normal fee
• Payments based on deliverables.
• Good reputation with all Certifying bodies.
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Process of FDA 510k Submission

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• Appoint an experienced Consulting
  The consultant or the consulting team should have through knowledge and previous experiences in Medical Device submissions to FDA. The consultants should take responsibility of your submissions and communications with FDA on behalf of customer till receipt of K number. 
• Determine your product (a) is a medical Device or (b) radiation emitting product:
  Once it is identified, proceed with compiling the FDA regulatory requirements required for marketing the product in US.
• Classify the medical Device:
  This will help us to make sure 510k route can be used to market along with device code submission procedure and other applicable compliance issues.
• Implement 21 CFR 820 if Applicable:
  If the product is not exempted from GMP, you need to implement GMP in the manufacturing location. This is not a requirement at for 510k submission, but all firms registered should be prepared to face Inspection, if failed FDA will issue warning letter to the manufacturer and you will be forced to withdraw products from the market.Read More >>
• Test the product/Equipment:
  For preparing FDA notification test reports and data sheets is very much essential. The applicable standards have to be identified and testing to be done from accredited laboratories.
• Review the Test report:
  Review of test reports to be carried out based on the standards and acceptance criteria. Any errors in the report cannot be used in 510k notification.
• Appoint US Agent:
  Appoint an US Agent for assisting FDA in communications with the foreign establishment, answering to questions concerning the foreign establishment's devices that are to be imported into the United States. 
• Prepare 510k Notification and Submit:
  Prepare 510k notification with the help of a consultant, and submit to FDA directly or through UL / Interk / BSI with the help of Consultant / US Agent.
• Register the establishment:
  Manufacturer has to register the establishment involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA under section 510(g) of the act. Read More >>
  An owner or operator of an establishment located in any of the State in US as defined in section 201(a)(1) of the act shall register its name, places of business and list the devices if interstate trading is done.
• List the device with FDA:
  Once the establishment registration is done, the products intended to sell in US has to list under registered establishments. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number. Read More >>
  Readers can contact us for more clarification.

  
  

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Medical Device

ISO, EU MDD and USFDA the definition of Medical device varies slightly. In short, a product can be called as a Medical Device if it is used for treatment, in diagnosis, therapy or in surgery. Manufacturing and sales of medical devices are highly controlled because of the complexities of the medical devices indented application. Country wise specific regulatory requirements are applicable for all medical devices.

 To export a medical device from one country to another, the importing countries regulatory requirements have to be met before exporting. Our service starts here!!!

• USA - FDA approval
• Europe - MDD
• Canada - Health Canada registration
• Japan - PAL approval
• China - SFDA approval
• Korea - KFDA approval
• India - CDSCO approval

Kindly look into various country specific requirements in detail throughout our website. Our one-stop shop approach offers a wide range of services designed to help export of medical devices to global markets fast

ISO 13485 Consultants

Medical Device component manufactures, finished good manufactures, Medical Software developers, Medical Device designers and Developers and pharmaceutical suppliers interested in enjoying worldwide presence has to prove there devices are manufactured under certain auditable standards which means it’s safe and effective. ISO 13485:2003 Certification is a solution for this issue!!!
    ISO 13485:2003 Certificate will be issued by an accredited third-party after assesses your compliance towards Medical Device Quality Management System. We are there to help you in the training, documentation, implementation, and internal audit. You will be getting much useful information while you continue reading our web site.