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)


RicoSolutions

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RicoSolutions

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