Startups Program
Is this program for me?
ISO 13485 Certified
We can support you to get ISO 13485 Certified.
Device to Market
We can support you to bring a medical device onto the market in either the U.S. or Europe.
Clinical Trials
We can support you to get your medical device into clinical trials in Europe or the U.S.
eQMS Software
We will provide you with our eQMS software for the first year for FREE
Feedback
In return we want to work with you to gather useful feedback to make both our software and quality management system better.
Quality Management System
We will provide you first with a basic set of SOPs, templates, training, checklists, forms and a quality system manual and then over the next months we will continue to improve these with your help to ensure that you have the best chance of reaching your goals. This quality system should be complete and compatible with the FDA requirements (21 CFR 820), the European requirements (Regulation (EU) 2017/745 on medical devices) and ISO 13485. We will also provide SOPs that are compatible with other common standards such as IEC 62304, IEC 6060-1, ISO 14971, ISO 10993-1, etc.
The basic quality system will include the following topics:
- Design and Development
- Non-conformities and CAPAs
- Repair/Rework
Monitoring and - Measuring Equipment
- Verification and Validation
- Shelf-life
- External Auditing
- Clinical Evaluation
- Management Reviews
- Customer Complaints and Feedback
- Infrastructure
- Software Validation
- Supplier Controls
- Biocompatibility
- Labeling and Intructions for Use
- Internal Auditing
- Servicing and Installation
- Production
- Work Environment and Contamination Control
- Purchasing Controls
- Cleaning, Sterlization and Reprocessing
- Transportation and Packaging
- Post-market Clinical Follow-up
We can also work with you to provide other specialist SOPs on request.
We believe that this is a great opportunity for startups to receive extra experienced help quickly at a discounted price.
FAQ
We want to make sure that we provide customers with the best eQMS software out there and a quality management system that is as light-weight, modular, compliant and will ensure medical device quality. The best way to do that? Work with customers! We want to team up with customers and work with them to ensure that they have the best experience they can have, including reaching their goals in the most fast-tracked efficient way possible.
We also want to work with Startups because they have unique requirements to have a quality system that is as lean as possible, as easy to use as possible, and one that still allows innovation. They need awesome software, and we want to be the ones that can provide!
This program is most adventageous for those that don’t already have a quality management system in place, because we plan to provide all the quality managemenet documentation you need to get started without a massive amount of customization. We are also looking for companies that are interested in using eQMS software. However, we also gladly take companies that have quality management gaps that they are looking to fill.
Already have a quality management system, but you are looking for an eQMS? We can also help you to digitize your system so that you can use it with our software, but this program is not suitable for that. Please contact us directly for more information of how we can help you.
You can apply for this program as long as it is available, but be aware that we only have space for about 5 companies in the program. Once we have 5 companies, we will need to close for applications.
We see this program as a team effort, and we can only make our software better if we can get timely feedback from you about how to improve. To do this, we need you to be using our software for your quality needs. This doesn’t mean that you have to exclusively use our software! Our eQMS software can compliment many other tools that you may be using, including other eQMS software. Speak to us about how our software can fit into the systems you have in place.
The first year of this program you receive the software free as well as discounted services. You also receive a quality management system. In the following years you will no longer need to purchase the quality management system documents as you will already have them. Therefore, you will only need to pay for your per-user licenses for the software and any other services that you wish to use with us in the future.
You are under no obligation to renew for next year, so you will need to make plans to download the relevant documentation you need to keep before your year expires. We can also expedite this export for you.
During this program, we hope to receive a lot of feedback that can help us improve our software. Everyone in the program will benefit from these improvements and as we will roll out all new features and improvements to everyone.
If a team in the program has an audit and some improvements need to be made to the quality system documentation, we will also provide other teams the option to benefit from the update as well.
We are primarily looking for companies that do not already have an established quality management system for this program. If you have an established system and are looking for eQMS software, we might still be able to help, so speak to us directly about your options.
If you change your mind, you can leave the program at any time. Be mindful that if the quality management system documentation has already been delivered to you, we will not be able to provide you with a full refund.
Suddenly realize you need more support than you thought? You can upgrade your plan anytime. Depending on your situation, you may also be able to downgrade your plan. Please speak to us about your options.
If you have some special requirements, we can customize this plan in many ways based on your needs. Contact us directly and we can prepare you a quote.
