Medical Devices
quality
Weprovidetechnicalandregulatorysupportformedicaldevicesandinvitrodiagnosticdevices,ensuringcompliancewiththeMDRandIVDR.
Weprovidetechnicalandregulatorysupportformedicaldevicesandinvitrodiagnosticdevices,ensuringcompliancewiththeMDRandIVDR.
Pharmilabisahighlyexperiencedproviderofcompletesolutionsforthedevelopment,regulation,andmarketplacementofcosmeticproducts,guaranteeinglegalcomplianceandqualityateverystep.
Fromclassification,documentation,andCEmarkingtoEUDAMEDsubmissionandISO13485implementation,weoffercomprehensivesolutionstailoredtoeachclient’sneeds.
Fromclassification,documentation,andCEmarkingtoEUDAMEDsubmissionandISO13485implementation,weoffercomprehensivesolutionstailoredtoeachclient’sneeds.
Pharmilabisahighlyexperiencedproviderofcompletesolutionsforthedevelopment,regulation,andmarketplacementofcosmeticproducts,guaranteeinglegalcomplianceandqualityateverystep.
Good Manufacturing and Distribution Practices
Microbiology and Physicochemicals
Good Manufacturing and Distribution Practices (GMP/GDP) are essential for maintaining the safety and quality of medical devices from production to delivery. Pharmilab helps companies implement and optimize these processes to ensure full compliance with MDR, IVDR, and ISO 13485.
Their services include analyzing current operations to identify gaps, strengthening quality management systems(improving traceability, documentation, and process validation), and providing audit preparation support to ensure you are ready for regulatory inspections.
Before placing detergents on the EU or UK markets, manufacturers must ensure compliance with several mandatory legislative acts.
The primary requirements include Regulation (EC) No 648/2004 on detergents and Regulation (EC) No 1272/2008 on classification and labelling, alongside the REACH Regulation.
Depending on the product's specific composition and intended use, additional rules regarding biocidal products or phosphorus compounds may also apply.
Beyond legal obligations, responsible brands are expected to adhere to good industry practices, such as guidelines from the A.I.S.E. and IFRA standards regarding fragrance safety.
Companies wishing to demonstrate further commitment to sustainability can also pursue voluntary initiatives like the Ecolabel certification, which recognizes products that meet high environmental standards throughout their life cycle.
Good Manufacturing and Distribution Practices (GMP/GDP) are essential for maintaining the safety and quality of medical devices from production to delivery. Pharmilab helps companies implement and optimize these processes to ensure full compliance with MDR, IVDR, and ISO 13485.
Their services include analyzing current operations to identify gaps, strengthening quality management systems(improving traceability, documentation, and process validation), and providing audit preparation support to ensure you are ready for regulatory inspections.
Implementation of ISO 13485
Mutual Recognition in the EU
ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry, crucial for regulatory compliance and CE marking. Pharmilab provides end-to-end support for implementing and maintaining a custom ISO 13485 system, tailored to your company's size.
Their services cover full QMS development (policy, risk management, supplier control), creating necessary procedures and work instructions, and supporting you through internal and external audits to achieve and maintain certification..
ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry, crucial for regulatory compliance and CE marking. Pharmilab provides end-to-end support for implementing and maintaining a custom ISO 13485 system, tailored to your company's size.
Their services cover full QMS development (policy, risk management, supplier control), creating necessary procedures and work instructions, and supporting you through internal and external audits to achieve and maintain certification..
ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry, crucial for regulatory compliance and CE marking. Pharmilab provides end-to-end support for implementing and maintaining a custom ISO 13485 system, tailored to your company's size.
Their services cover full QMS development (policy, risk management, supplier control), creating necessary procedures and work instructions, and supporting you through internal and external audits to achieve and maintain certification..
Support in Structuring the Quality System
Request for assignment of a National Product Code (CNP)
A well-structured Quality Management System (QMS) is fundamental for regulatory compliance and operational efficiency, even if formal certification is not yet required. Pharmilab provides strategic support to build or improve your QMS, focusing on documentation, internal processes, and good practices. This ensures your organization meets the legal standards of MDR and IVDR, creating a solid foundation for device safety throughout its lifecycle.
A well-structured Quality Management System (QMS) is fundamental for regulatory compliance and operational efficiency, even if formal certification is not yet required. Pharmilab provides strategic support to build or improve your QMS, focusing on documentation, internal processes, and good practices. This ensures your organization meets the legal standards of MDR and IVDR, creating a solid foundation for device safety throughout its lifecycle.
A well-structured Quality Management System (QMS) is fundamental for regulatory compliance and operational efficiency, even if formal certification is not yet required. Pharmilab provides strategic support to build or improve your QMS, focusing on documentation, internal processes, and good practices. This ensures your organization meets the legal standards of MDR and IVDR, creating a solid foundation for device safety throughout its lifecycle.
Preparation for Audits and Certifications
Labeling
Achieving and maintaining ISO 13485 and ISO 9001 certifications requires rigorous preparation. Pharmilab provides comprehensive support throughout the audit lifecycle to ensure your Quality Management System (QMS) is compliant.
Their services include preparing for certification or transition audits, conducting mandatory internal audits, and providing real-time support during external inspections. Additionally, they assist in resolving non-conformities and managing all necessary audit documentation, such as reports and action plans.
Achieving and maintaining ISO 13485 and ISO 9001 certifications requires rigorous preparation. Pharmilab provides comprehensive support throughout the audit lifecycle to ensure your Quality Management System (QMS) is compliant.
Their services include preparing for certification or transition audits, conducting mandatory internal audits, and providing real-time support during external inspections. Additionally, they assist in resolving non-conformities and managing all necessary audit documentation, such as reports and action plans.
Achieving and maintaining ISO 13485 and ISO 9001 certifications requires rigorous preparation. Pharmilab provides comprehensive support throughout the audit lifecycle to ensure your Quality Management System (QMS) is compliant.
Their services include preparing for certification or transition audits, conducting mandatory internal audits, and providing real-time support during external inspections. Additionally, they assist in resolving non-conformities and managing all necessary audit documentation, such as reports and action plans.
Support in Risk Analysis Development
Labeling
Risk management is a mandatory requirement for medical devices under MDR and IVDR, governed by the ISO 14971 standard. Pharmilab provides specialized support to structure this process across the entire device lifecycle—from design and manufacture to disposal.
Their services include conducting hazard assessments, generating essential documentation (such as Risk Management Plans and Final Reports), and integrating risk data with clinical evaluations and post-market surveillance (PMS) to ensure continuous compliance.
EUDAMED is the centralized EU database designed to ensure transparency and traceability for medical devices under MDR and IVDR regulations. It is a mandatory tool for all stakeholders, including manufacturers, importers, and competent authorities. Pharmilab provides full support for the required registration and data submission processes, ensuring your company meets all legal and technical obligations.
EUDAMED is the centralized EU database designed to ensure transparency and traceability for medical devices under MDR and IVDR regulations.
It is a mandatory tool for all stakeholders, including manufacturers, importers, and competent authorities. Pharmilab provides full support for the required registration and data submission processes, ensuring your company meets all legal and technical obligations.
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Conquer the world
with your brand
Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services