D´Silva medical device consulting endeavors to bring high-level expertise and individual experts to your needs.
Dr. Lindsay D´Silva
Founder
Dr. Lindsay D’Silva has worked hands on with patients and clinical professionals in various fields of medicine. He also has significant worldwide experience with regulators, notified bodies, medical ethics committees, medical device entrepreneurs, contract and legal manufacturers and brings all this experience to cater to your needs. The concept behind D’Silva medical device consulting is to collaborate with experts, so that your product and innovation is secured in all aspects of its life cycle.
In addition to Lindsay’s knowledge and experience, he works with independent consultants and subject matter experts within the areas of Clinical, Biocompatibility, Toxicology, Sterilization, Engineering, Manufacturing, Regulatory Quality and Cleanroom Environment expertise. Therefore, you are always facilitated by a team who has worked, learnt, and succeeded together and this experience enables the exact requirements and strategies for your product’s needs. This approach saves you time, money and ensures a safe product for patients and health care professionals.
It is D’Silva’s mission to ensure that medical devices are designed and developed in a safe and efficient way.
The vision of D’Silva Medical Device Consulting is to bring talent, ideas, experts, and innovation together.
Dr. Lindsay D’Silva has worked hands on with patients and clinical professionals in various fields of medicine. He also has significant worldwide experience with regulators, notified bodies, medical ethics committees, medical device entrepreneurs, contract and legal manufacturers and brings all this experience to cater to your needs. The concept behind D’Silva medical device consulting is to collaborate with experts, so that your product and innovation is secured in all aspects of its life cycle.
In addition to Lindsay’s knowledge and experience, he works with independent consultants and subject matter experts within the areas of Clinical, Biocompatibility, Toxicology, Sterilization, Engineering, Manufacturing, Regulatory Quality and Cleanroom Environment expertise. Therefore, you are always facilitated by a team who has worked, learnt, and succeeded together and this experience enables the exact requirements and strategies for your product’s needs. This approach saves you time, money and ensures a safe product for patients and health care professionals.
It is D’Silva’s mission to ensure that medical devices are designed and developed in a safe and efficient way.
The vision of D’Silva medical device consulting is to bring talent, ideas, experts, and innovation together.
After completing his degree in sports medicine, Lindsay completed his PhD characterising the cardiovascular, haemodynamic and autonomic nervous system function in pregnant Woman. This longitudinal clinical study was the first to characterise the normal physiological changes associated with pregnancy which was used as a baseline for complications associated during pregnancy and activity/lifestyle choices during pregnancy. Lindsay then completed his post-doctoral clinical research fellowship in the field of coagulation, thrombosis and haemostasis working within the accident and emergency department for the development of a blood biomarker within a wide pathological patient cohort of ischemic stroke, deep vein thrombosis, sepsis, myocardial ischemic heart disease and burns. Lindsay is also a qualified cardiovascular sonographer, advanced paediatric and adult phlebotomist and experienced in other imaging modalities such as fluoroscopy scanning electron microscopy and histology.
After leaving the United Kingdom in 2016, Lindsay moved to Germany, Dresden where he applied his clinical experience to the MedTech industry (Contract Medical International, Heraeus Medical Components, Triticum-Medical, Deerfield Healthcare and Nano4Imaging) working with inventors, skilled engineers, key opinion leaders in specialised clinical fields for the design, development and regulatory approval of primarily novel high-risk medical devices which are currently placed on the market world-wide. This naturally led to the involvement with animal trials, cadaver experiments, clinical studies, research institutes, competent authorities, medical ethics committees, notified bodies, distributors, and funding organisations.
Lindsay’s clinical and regulatory experience covers medical devices in the areas of cardiovascular implants, vascular implants, complex catheters, introducer sheaths, thrombectomy devices, short-term gastrointestinal implants, guidewires, blood collection systems, ablation systems, vascular closure devices and brachytherapy procedure kits. In addition to regulatory submissions, Lindsay has also significant experience in setting-up authorized representative and importer activities for legal manufacturers based outside the European Union.
Lindsay is also a qualified lead auditor for MDSAP, ISO 13485 and critical suppliers. He is also experienced in setting up electronic quality managements systems (eQMS) and enterprise resource planning (ERP) software systems for small and medium sized companies.
D´Silva supports all stages of medical device development for access to the European, Asian, Latin American, Canadian, and U.S Markets.