Cliniflux is a team of highly qualified professionals with in-depth experience in design, production, quality assurance, regulatory approval and marketing of novel healthcare products and technologies. As former industry leaders and healthcare regulatory agency workers ourselves, we possess service mindset and expertise required to balance regulatory risks with business needs.
We exclusively serve developers, manufacturers, importers and distributors seeking to market their medical devices and IVDs. Our comprehensive services range from Technical Consultation, Quality Assurance consultation, Regulatory Affair consultation, Authorized Representation, and Person Responsible for Regulatory Compliance (PRRC).
Through close collaboration with your internal teams, our regulatory, compliance, and quality specialists guide you to practical solutions that help you bring safer products to market and maintain compliance.
Backed by our integrity, experience, and track record in providing high-value solutions that exceed expectations, Cliniflux offers you a reliable partnership in the rapidly changing regulations and global standards.
Why appoint Cliniflux?
Cliniflux offers following key advantages over its competitors:
> Our consultants are honest, responsible, and experienced professionals, dedicated to your success.
> We take a solution-based approach tailored to your needs.
> We never propose more work than is essential.
> Our charges are competitive.
> If we do not feel we are qualified to do a project, or we feel there is a less expensive alternative, we will inform you accordingly.
Company Details
- Founded
- -
- Address
- Cambridge, Gb
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Keywords
- Our Consultation Services encompass M&A Integration, transition strategies, Gap assessment, Remediation, Technical writing (Procedure, Plan, Report) and Project Management for: Design Control, verification and validation, Design History File Optimization, SaMD development and validation; Quality System Remediation for MDR/IVDR compliance, ISO-13485 Implementation and maintenance, Internal Audits and Supplier Audits; MDR and IVDR compliance, device Classification, GSPR remediation, Labelling, IFU, Advertising & Promotion review, Unique Device Identification (UDI), Technical Documentation for CE marking, UKCA marking and 510(k) approval, Risk Management, Usability Engineering, Biological Evaluation, Clinical Evaluation (for Medical Devices), Performance Evaluation (for IVDs), Software compliance & security, PMS/PSUR, PMCF, Vigilance and Incident reporting, Product registration; EU Authorized Representative (EC REP), UK Responsible Person, PRRC (Person Responsible for Regulatory Compliance) services for Micro and Small enterprises; and Tailored support for Virtual manufacturers (Own Branders) importers and distributors of Medical devices and IVDs to meet their compliance obligations..
- HQ
- Cambridge
- Competitors
- Medicom Pharma GmbH.
Cliniflux Questions
Cliniflux's LinkedIn profile is https://uk.linkedin.com/company/cliniflux
Cliniflux's industry is
Business Consulting and Services
Cliniflux's top competitors are
Medicom Pharma Gmbh.
Cliniflux's categories are Business Consulting and Services
Cliniflux's founding year is 2010
