Why it’s important to work with US FDA consultant for compliance.

 Without going into definition of compliance as it is clear precise word but has lot of implications on your product and business. Compliance is not a choice, but it is must. It is not debatable. Though guidelines are available it becomes difficult to interpret sometime leading to wrong path. Taking compliance lightly may lead to product safety issues thus heavy price to business.

In Medical device field like any other pharmaceutical, cosmetic product field, regulators has laid down certain rules and conditions for product safety and for the benefit of consumers who uses these products. Once you are compliant to say, US FDA requirement, it automatically means that products are safe to use, thus it gives sort of certification to consumers.

Having said this, why it is necessary to have US FDA consultant? Regulatory requirements are everchanging phenomenon and it is difficult to keep chasing the same and understanding the compliance need for each requirement. That is where these consultants play important role. They are very close to such changes or new requirement and being in that atmosphere for long time, they understand these rules much better way. They also have access to various contacts in FDA whom they can enquire and clarify for any doubt in interpreting the compliance requirement. US FDA consultants are therefore up to date to ever changing or new rules and compliance requirements.

One of the best skills they have is wide experience of auditing in past where they have audited various firms who opted for US FDA compliance to do business with US clients. During audit they come across various non compliances either due to lack of proper understanding of requirement or ignorance towards requirements. Thus, they know very well that why many of US FDA approval seekers lack where in general and in specific. This information is handy like ready reckoner.

Now let us assume that you are in Medical Device product for US market, and you also have experienced regulatory people to support you. Do you still need US FDA consultant? Yes, because you may make some critical mistake and then face huge challenge to sort this out and loose lot of time while the consultant can come as handy resource for such issues.

Following area are important for compliance and one can seek consultant’s support in understanding requirement, methodology to comply and verification of compliance.

1      Your product’s present status with respect to marketing in US and its legal status.

2.       Quality system readiness.

3.       Auditing requirement, readiness through pre audit.

4.       Complex Validation services.

5.       Product recall or complaint handling issues

6.       Staff training.

7.       Supply chain management if certain product need special supply chain requirement.

8.       Some special requirements for clinical, microbiological, in Vitro toxicological requirement.

Medical device depending on its class, has various complex requirements so it may become necessary that not just consultant, but consultant firm may be needed for assistance. Consultant firm will have various experts in different area which may become handy through single window.

IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.Upon completion of Engineering & QMS documentation the regulatory team of IZiel conducts the predicate device search, comparative analysis and ensure all the necessary standards are complied with. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants. Our highly experienced US regulatory consultants include Ex-FDA Auditors, have conducted 3500 + reviews and approvals and have experience with Class I, II & III devices in Cardiology, Neurology, Image Diagnostics and Orthopaedic products.