About Us
Our Mission
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 help device companies meet registration requirements in the world’s biggest markets. With a team of experienced RA/QA consultants working across the globe, we can assist with device registrations, quality management system implementation, in-country representation, regulatory strategy, and more. Learn more about our approach to device market compliance here.
In Rico solutions each customer is unique, so we adjust service and pricing to their specific requirements. As compliance partners – whether it’s a certification experience from one source or perhaps just guidance on the regulatory pathway – we always put our efforts to accelerate innovation and promote the breakthrough of great ideas.
Rico Solutions provide the most suited and tailored assessment procedures for clients. The services include:
- Acquisition due diligence and integration of QMS.
- Regulatory strategies and gap analysis
- In-country Representative
- Medical Device Post-Market Surveillance
- EU & UK MDR and IVDR implementation
- Technical Files and Design Dossier Development
- ISO 13485 implementation for startups including digital devices
- Risk Management
- AI and ML and software as Medical Device (SaMD) compliance
- Environmental and Health & Safety
- Good Distribution Practices for Pharmaceutical
- MDSAP program
- Worldwide regulatory submissions including USA, China, Japan, Taiwan, Australia, Hong Kong, Saudi Arabia, Brazil (INMETRO), Iran, etc.
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)
