Our consultants train and assist to answer questions concerning company- and product-approval. We are experts for Modern Concepts, DiGAs, PoC-Solutions but also for classical med-tech products. It provides Business Planning for Conventional and Future Technologies, Certification Strategies for Modern Treatment Concepts, Hands-on and Assistance in Document Development, Coaching and Teaching as well as Auditing and Pre-Assessments. surgeSupply defines Regulatory Thinking® as an interdisciplinary regulatory strategy that knows existing rules, regulations, common specifications, standards and norms, adapts them to common and future technologies, uncommon healthcare settings or any new or unknown challenges, and applies them in the spirit of the “original idea.”
The journey from an idea in medical life science to the market entry of the final product is marked by many obstacles, especially in terms of regulatory. The wrong strategy is costly and time-consuming and thus hinders the quick market success of potentially life-changing products.
We made a virtue out of this necessity and developed Regulatory Thinking® as a more positive and enabling mindset. Norms and standards for example can be seen as a treasure chest filled with valuable methods that provide a common thread for business and product development. Therefore, we want to encourage innovators to proactively and strategically use those methods hidden e.g. in the ISO 13485, rather than seeing them as sticking points.
We provide you with our hands-on experience. Profit from our elaborated basic documents. Our personalized procedures, forms, plans and reports assist you in all your duties during design & development, risk management, usability engineering, product verification and clinical evaluation.
We help you be your best! By not only providing our own services but also enabling you to be an expert yourself! We provide 1:1 coaching sessions, seminars, training.
Auditing and Pre-Assessment
Are you ready for your audit? Is your quality management set?
Let us help you answer these questions by auditing, pre-evaluating, helping you integrate processes in your business plan.
Digital Healthcare Applications
We assist you in the documentation, verification, and validation of your Healthcare App or your SaMD (software as a medical device). We guide you through the complete certification process including the negotiations with BfArM. Clinical Evaluation and the use of Real-World Data are also at the centre of our DiGA services. ➔ Our clinical investigators, medical writers, and technical assessors assist in defining your clinical evaluation concept. Together with our clients and based on the functionality of the SaMD / Healthcare App we define safety, performance, and efficacy endpoints and anchor them in the clinical evaluation protocol. ➔ Statistical methods and drop-out calculations complete our services. We are auditing the CRO or the investigating healthcare unit according to related quality standards or GCP requirements. ➔ Having in mind the positive healthcare effect we monitor your clinical evaluation, analyze the results obtained from the evaluation of the clinical study protocol, or evaluate your clinical data concept.
Point of Care
The advances made in the last decade in manufacturing, optimizing, and delivering products used in the healthcare sector, directly to the patient, bring both benefits to the patient and some challenges to the manufacturer or user of these kinds of productsThus, the healthcare industry is in a transformative change: one of the key enablers of these changes is the proliferation of point-of-care (PoC) technologies, which can improve clinical outcomes and reduce costs by increasing access. PoC technologies have the potential to improve the management and treatment of various diseases and conditions, not only in resource-limited settings, where healthcare infrastructure is weak and access to quality and timely care is challenging. PoC technologies are gaining ground in four areas in particular: (1) IVD, (2) SaMD, (3) surgery, specifically in orthopedics, CMF, and dental surgery, and (4) preparation of surgeryWhile PoC solutions in the diagnostic or SaMD area make the products available to the patient 24/7 mostly in their home environment, PoC technologies in the orthopedic-surgical area bring the products directly to the user in the outpatient clinic or hospital. We assist you in defining and implementing a compelling regulatory strategy and certification pathway for your PoC device, always respecting the requirements given in MDR (EU) 2017/745.