One of the most serious challenges while procuring products internationally is to control the production quality of the manufacturer.
Checking that production meets specifications and abides by quality standards can be expensive and time-consuming. Our management system allows you to ensure quality when it comes to manufacturing inspection, documentation and certificate verification, pre-shipment inspection, product quality control and packaging and container verification.
If you need something that is not on the market yet, we will look for original equipment manufacturers (OEMs). They deliver innovative products beating competitors without compromising quality. During the design phase, we directly negotiate with selected suppliers to meet your every need.
Typically, we control completing the design, advancing to the prototype and NPI stages, and the start of the production of a device or medication. We sort all required regulatory approvals, logistics and support.
Our task is to find what you need and bring it to your door sustainably and with immediate reliability to stay ahead of the competition.
When an OEM first begins work on a new medical device or medication, there are several vital milestones required to ensure compliance. We make sure to tick off every item on this list.
Appropriate manufacturing location. The priority is ensuring the product is designed at the right location. The facility must have the proper qualifications, registration and ISO certifications.
Detailed contract and pricing. The agreement should define the roles and responsibilities of each stakeholder. The contract must reflect all details and manufacturing workflow that ensure product quality throughout production.
Complete design transfer. The design transfer includes all the necessary information to build the product. It’s essential the product design be transferred according to rules. There must be critical to quality (CTQ) points identified on all product prints for inspections.
Clear procedures. The new product introduction (NPI) process must ensure no issues during manufacturing compromise quality or deadlines.