Request For Quote (RFQ) - MDR Technical Documentation Please fill the below form and submit online. 1. GENERAL INFORMATION 1.1 Name of the Company : 1.2 Contact Person : Mr Mrs Dr Prof Ms 1.3 Job Title : 1.4 Contact Number : 1.5 Contact Email : 1.6 Website Address : 2. MANUFACTURER INFORMATION 2.1 Do you have valid ISO 13485 certificate? Yes No 2.2 Are you manufacturing a complete device? Yes No 2.3 Are you manufacturing a device which is a component for other medical device? Yes No 2.4 Are you manufacturing and selling the medical device in your company name? Yes No 2.5 Are you packing the manufactured device and selling in your company name? Yes No 2.6 Are you doing only assembly and packing of the device? Yes No 2.7 Is the device manufactured using 100% outsourced Components? Yes No 3. ADMINISTRATIVE INFORMATION 3.1 Notified Body Interested? Select BSI/SGS TUV(R)/TUV(SUD) 3EC / ECM / ITC DNV / DQS/ INTERTEK PCBC/LME MED DERKA/ UL GMED Others 3.2 If Others Mention the Name : Organization should appoint an expert to interact with consultant for developing and collecting necessary information from various departments like Manufacturing, Quality, Design, sales, Service, Installation, customer service etc. 3.3 What is his/her Background? 3.4 Product Knowledge : Select Good Poor Average 4. SCOPE OF WORK TO BE UNDERTAKEN BY I 3 CONSULTING 4.1 General Guidance : Yes No 4.2 Technical File / Design Dossier preparation : Yes No 4.3 Label Review : Yes No 4.4 Closing of Reviewer/Audit Comments : Yes No 5. MEDICAL DEVICE DESCRIPTION 5.1 Name of the Medical device : 5.2 Intended use of the device [ how the medical devices serves the purpose of the device ]: 5.3 Class of Medical Device as per MDD : Select Class 1 Class 1 Sterile Class 1 Measuring Class 11 a Class 11 b Class 111 5.4 Is it an invitro diagnostic reagent? Yes No 5.5 Is it a standalone medical software? Yes No 5.6 Is the Medical Device used for measuring any Human body attributes? Yes No 5.7 Is the Device used externally? Yes No 5.8 Duration of contact with human body. : Less than 60 mts. Less than 30 days. More than 30 days. 5.9 Does the medical device penetrates inside the body : Yes No (a) With the help of surgical procedure. (b) Body orifice. 5.10 Totally introduced into the body through surgical procedure : Yes No 5.11 Partially introduced into the body through surgical procedure : Yes No 5.12 Is it a reusable medical device? Yes No 5.13 Are the medical device functions on electricity or any source of energy? Yes No 5.14 Does the medical device functions in combination with other medical device? Yes No 5.15 Is the medical device used for Diagnostic purpose? Yes No 5.16 Is the device used in central circulatory system? Yes No 5.17 Is the device used in central nervous system? Yes No 5.18 Is the medical device is made up of animal origin raw materials? Yes No 5.19 Does the medical device contains any drug? Yes No 5.20 Medical Device packed in : Sterile Non Sterile 5.21 Medical Device tested as per : Select IEC 60601-1 3rd Edition IEC 60601-1 + Product Testing ISO 10993-1 Others Not Tested If OTHERS please mention : 5.22 Attach the photograph of the product : 5.23 Upload product brochure/ manual / Specification/ IFU : 5.24 Information provided by : Mr Mrs Dr Prof Ms 5.25 Date : Receive copy of the filled RFQ, Please provide email ID :
