Regumedic is a company specialized in Regulatory Affairs, Quality Management System and Clinical Research.
We offer all the support that the medical device manufacturer needs and we interface between manufacturers, distributors, certification agencies and testing laboratories.
We have extensive experience in preparing documents for the Technical File or Product Master Record, such as:
• Risk Management File (Risk Analysis and Management);
• Usability Documents (Usability Plan and Report);
• Biological Risk Assessment including Biological Risk Assessment and Toxicological Risk Assessment;
• Post-Market Monitoring (PMS/PSUR - Post-Market) including Post-Market Follow-up (PMCF - Post-Market Clinical Follow-up);
• Clinical Evaluation;
• Clinical Investigation;
• Registration of raw materials in the EDQM (European Directorate for the Quality of Medicines).
We also offer services for the revitalization and implementation of the Quality Management System for Good Manufacturing Practices Certificate (CBPF), Good Distribution and Storage Practices Certificate (CBPDA) and ISO 13485 Certification.
We assist in the interpretation of regulatory requirements of national and international standards, as well as, we evaluate the GAP to meet these requirements in the Quality Management System and in the Technical File.
We prepare all documents necessary for CE Mark Certification in accordance with all requirements of Regulation (EU) 2017/745.
We provide 100% customized training according to your demand.
We carry out an internal audit, with an ISO 13485 lead auditor, and assist in the treatment of non-conformities.
We have specialized and qualified consultants, with deep experience to offer the solution your company needs to market products in Latin America, Europe and other countries.
Get in touch with us now for a personalized proposal.
Company Details
- Employees
- 2
- Founded
- -
- Address
- Belo Horizonte, Minas Gerais 30220-000, Br
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://www.regumedic.com/
- Keywords
- Assuntos Regulatórios, Pesquisa clínica, Gestão da Qualidade, Registro de produtos, Boas Práticas de Fabricação, Marca CE, EDQM, Produtos para saúde, Produto Eletromédico, Boas Práticas de Distribuição e Armazenamento, Gerenciamento de Risco, Pericárdio Bovino, Investigação clínica, Reclamação de Cliente, ANVISA, Acompanhamento clínico pós-comercialização (Post-Market Clinical Follow up studies - PMCF)., Vigilância pós-mercado (Post Market Surveillance - PMS), Relatório de Avaliação Clínica (Clinical Evaluation Report - CER), ISO 13485, GMP, Eletromédicos, Não conformidade, Tecnovigilância, MDR 2017/745, Ação Corretiva e Ação Preventiva (CAPA), Usabilidade, Biocompatibilidade, Instrução de Uso, mdr.
- HQ
- Belo Horizonte, Minas Gerais
- Competitors
- Lycens Assuntos Regulatórios, Visionar Consultoria Regulatória | Assuntos Regulatórios, Individual Consultoria Regulatória & Científica, TGL EXPERTISE REGULATÓRIOS | Assuntos Regulatórios, Visanco - Consultoria em Assuntos Regulatórios na Área de Vigilância Sanitária, Vera Rosas Group - Brazilian Regulatory Affairs, Vita Pharma Consulting, CRIALI Assuntos Regulatórios, Passarini Group, Meta Regulatória.
Regumedic Regulatory Affairs Questions
Regumedic Regulatory Affairs's website is https://www.regumedic.com/
Regumedic Regulatory Affairs's LinkedIn profile is https://br.linkedin.com/company/regumedicbr
Regumedic Regulatory Affairs has
2 employees.
View email and phone details for 2
employees at Regumedic Regulatory Affairs.
Regumedic Regulatory Affairs's industry is
Business Consulting and Services
Regumedic Regulatory Affairs's top competitors are
Lycens Assuntos Regulatórios,
Visionar Consultoria Regulatória | Assuntos Regulatórios,
Individual Consultoria Regulatória & Científica,
Tgl Expertise Regulatórios | Assuntos Regulatórios,
Visanco - Consultoria Em Assuntos Regulatórios Na Área De Vigilância Sanitária,
Vera Rosas Group - Brazilian Regulatory Affairs,
Vita Pharma Consulting,
Criali Assuntos Regulatórios,
Passarini Group,
Meta Regulatória.
Regumedic Regulatory Affairs's categories are Business Consulting and Services
Regumedic Regulatory Affairs's founding year is 2004
