Support for regulatory affairs that extends beyond entries ALS International has the expertise and range of product capabilities to demonstrate your successful and safe devices. Our well-rounded strategy and key heading boost favorable business effects and position your organization for faster advancement. From the initial regulatory plan all the way through clearance and the post-market period, we provide a full spectrum of regulatory services. Our understanding of the legal requirements will make the path to market easier. Our regulatory plans can include all aspects of the device’s development and marketing, or they might concentrate on certain issues like device modifications or regulatory requirements.
CLINICAL REGULATORY AFFAIRS
ALT is in a unique position to assist you in developing a plan for delivering thorough clinical evidence and analysis. We will set up your team and paperwork in accordance with what the notified entities are anticipating. Whether the clinical evaluation is based on clinical data obtained from a literature review of comparable devices or on clinical data available on the device itself through clinical trials and post market surveillance, we can provide clinical evaluation plans and reports to meet the requirements of the MDD or MDR and pertinent guidance documents. This includes taking the lead on or providing assistance for the work necessary to show equivalence to other products on the market.
QUALITY EXPERTISE ASSURANCE
We can offer the best assistance, whether you need help with internal audits and CAPAs or want to hand off the management of your whole quality management system. We may offer custom quality management system methods to ensure the smooth operation of the business and compliance with pertinent QMS requirements by thoroughly understanding the operations of a firm. Our quality consultants for medical devices are experts in quality control procedures.