SimplerQMS comes with templates and procedures that are ready to use in your medical device start-up. In this way, we minimize the time and effort needed on your end.
Our onboarding-team will get you up on running fast - no matter if you are starting from scratch or already have a QMS in place.
From garage-startup to established company
Whether you are an early start-up or have products on the market SimplerQMS covers your needs. Our pre-defined processes are fully compliant with the requirements of the FDA and the European Union notified bodies. This enables you to focus on your core processes.
Our implementation process is based on 30+ years of medical device experience. We are strong believers in best practice industry processes. However, we know that every company and product is different. Therefore, we work with you during an online design workshop to understand your business rules, workflow etc.
The training course provides your team with the skills and knowledge required to run your operations.
Before go-live we recommend that an audit is conducted. This will leave you with an audit report, which is your first line of defence during an inspection.
SimplerQMS is your shortcut to market access. We provide a preconfigured Quality Management System and a validated Part 11 compliant Document Management System for managing your Quality Handbook and Design History File efficiently and digitally.
Our solution is fully validated, under change control and runs on a qualified data center - ready for regulatory audits and inspections.