MEDLOFT helps you ensure that your medical device complies with the applicable standards and regulatory requirements. We know how difficult this can be for start-ups or for a mature company at the initial concept definition phases. Defining the design inputs including functional, performance, safety and regulatory requirements is a core activity within the design process of a medical device. MEDLOFT experts can support you on defining these inputs, evaluation of risks related to the clinical hazards and validating your design by preparing an effective traceability matrix.
MEDLOFT Design Assurance services include;
- Design Verification and Validation
- Human Factors/Usability Engineering Study
- Risk Management
- Design Quality Assurance
- Design Quality Engineering (Software, electromechanical, sterile disposables)
On the other hand, verification and validation protocols have become a very important step of design process. MEDLOFT experts can review the applicable standard requirements together with your technical team and support you on defining effective protocols and establishing clear report formats which will be an essential part of your technical file.
You may contact MEDLOFT experts to establish a strong process which will enable you to identify device features that should be optimized throughout the entire life cycle of the medical device. Don’t forget, with an effective risk management you can improve the usability of your device and validation testing and usability engineering, will reduce incidents and product recalls.
You can ensure safety of your medical device with MEDLOFT.