Frequently Asked Questions
Learn More About Our Approach
How do I know that XportKat is the right compliance consultancy for me?
At XportKat, we strive to help devoted teams growing into future hidden champions realize their dreams by bringing their products in HealthTech/MedTech, both software and hardware, to new export markets.
Even if you seem to lack the right expertise within your team, we believe that it’s your enormous sincere desire to achieve the goal may be one of the most crucial success factors. If your desire is as great as your vision, then, hand on heart, we’re ready to conduct a preliminary internal audit of your product and the existing management system.
Besides looking into the requirements of the target market regulatory, we may recommend our partners that may give a more detailed consultation on attracting various financial instruments to boost your project.
Being very connected to our customers we’re inspired to offer our customers solutions and advice that, among other things, allow them to avoid excessive staff, while successfully managing the growth at the stage where your business has now been passing by.
Сlinical trials in the EU to verify our MVP may seem pretty costly for our startup. Can you recommend any alternative solutions for clinical trials to be performed with reliable dataset quality at a lower price?
Yes, we can facilitate clinical trials, for instance, at Belarus-based clinics fully meeting the requirements of GCP and ISO 14155. So far, we’ve been continuously gaining positive experience in clinical trials that are accepted by renowned NBs in the EU countries.
Our service includes the selection of medical consultants, doctors, and the necessary clinic. So, all in all the full costs of clinical trials to confirm the safety and performance of your medical device or your MVP are likely to get reduced by several times compared to the trials held in the Central or Eastern Europe.
How do you customize your services for niche companies?
Before working out a compliance solution, we carefully study the market requirements specifically for the type of your product and your niche market. We love to work with open-minded people and devoted teams. If not, we’d rather focus on other projects.
Estimating the project, we explore together the chances for the alternative compliance path trails to certify your product and/or your management system. After that, we will be able to offer you a few options that would, firstly, implement your strategy, and, secondly, match your budget to achieve the goal.
If we feel that there’s something that makes us doubt the project or your niche is too vulnerable, we’ll share this with you straight away. We greatly appreciate sincerity, time value and the benefits we bring to business of our customers in various niches, and will do our utmost so that you could discover your way as quickly as possible and at the lowest cost.