Rico Solutions Limited is a fast-growing organization with global quality and regulatory expertise to get your medical device (s) including IVDs from concept to time to market. We provide expertise in medical devices product development, regulatory affairs and quality management and pharmaceutical GDP consultancy. We also, provide expertise in clinical and performance evaluations. Our global team comprised of engineers, clinicians, scientists’ former regulators and registrars. Our team at Rico share a common understanding of quality and responsibility. Rico Solutions provide most suited and tailored assessment procedures for clients. The services include: Acquisition due diligence and integration of QMS. EU and UK Authorised Representative EU & UK MDR implementation Technical Files ISO 13485 implementation for startups including digital devices Risk Management New product Development including AI and ML Environmental and Health & Safety Good Distribution practices for Pharmaceutical MDSAP program Worldwide regulatory submissions including USA, China, Japan, Taiwan, Australia, Hong Kong, Saudi Arabia and Brazil (INMETRO) We also, assist your medical device compliance in the below areas: Certification services Clinical Evaluations to literature data Supporting Biocompatibility evaluation protocols Audits – Supplier Audits, Gap analysis Audits, Internal Audits, FDA cGMP audits Hygienic qualification of production facilities Microbiological tests of products before and after sterilization Product control for possible toxic residues from the sterilization process Training including QMS/auditing (ISO 13485, 14001; 45001, Internal auditing), global regulations (CE marking, FDA, etc), Sterilization (radiation, ethylene oxide, steam). Risk Management (ISO 14971) and Product safety and EMC (the IEC 60601 series)
