1.3 The processes required by this Schedule, which are applicable to the medical device and in-vitro diagnostic medical device, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer's quality management system. 1.4 If a manufacturer engages in only some operations subject to the requirements of this Part, and not in oth ...

When evaluating a consulting firm, consider the factors mentioned earlier, such as their experience, track record, client testimonials, transparency, and adherence to legal and ethical standards. Additionally, you may want to reach out to the firm directly, discuss your specific needs, and ask for references or case studies that demonstrate their expertise in the field of drug licensing and regula ...