CE Marking by Asphalion MedTech
Ensuring Your Medical Devices Meet European Standards
Proven Expertise
With years of experience and a deep understanding of EU regulations, Asphalion MedTech ensures that your medical device journey through CE Marking is smooth and compliant.
Integrated Services
Leverage our full range of MedTech services, including regulatory consulting and quality management systems development to enhance your product’s market readiness.
Strategic Guidance
Receive strategic advice tailored to your specific needs, helping you overcome potential hurdles and accelerate market entry.
CE Marking Services
Achieving CE Marking is crucial for medical devices intended for the European market.
Asphalion MedTech, a specialized unit within Asphalion, provides comprehensive guidance and expert services to navigate the complexities of CE certification, ensuring your products comply with EU regulations.
- Gap Analysis:
Assessment of your device and/or your company against all relevant CE and ISO 13485 requirements to identify compliance gaps. - Technical Documentation:
Complete assistance in preparing and reviewing the necessary documentation including Clinical Evaluation, Technical Files, GSPRs and Declarations of Conformity. - Regulatory Strategy:
Developing and implementing a tailored regulatory roadmap to streamline the approval process.
Meet our experts!
Talyta Carteano
Medical Device Director | Lead Auditor
Talyta Carteano is a highly experienced professional in the medical device industry. With over 10 years of experience in the field, she has a strong background in research and development, as well as regulatory affairs.
Carteano is a key figure in the medical device industry, particularly in the context of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
She actively contributes to discussions and shares her expertise on topics related to medical devices, quality assurance, and regulatory affairs.
As the Medical Device Director and Lead Auditor at Asphalion, Talyta provides valuable insights and guidance to clients in the medical device industry. Her extensive knowledge and experience make her a respected professional in the field.
“Asphalion MedTech offers a complete portfolio of Medical Device solutions, based on our 15+ years of expertise in the area.
We can adapt to each and all of our client’s needs with total flexibility for a tailor-made approach, always striving to meet the highest quality standards”
Achieve CE Marking with Confidence
Begin your journey to compliance and market success!
Contact us to discuss your CE Marking needs and how we can assist you.
Asphalion MedTech is the specialized division of Asphalion, dedicated to providing comprehensive support throughout the development, certification, registration, and post-marketing phases of Medical Devices, In Vitro Diagnostics (IVDs), and Combination Products.
Our expertise spans Europe, the US, and other global regions, ensuring that your products meet stringent regulatory standards and achieve market success.
Our services include Regulatory Roadmaps and Feasibility Assessments (EU & US), Regulatory Strategy, Country-Specific Regulatory Support, Conformity Assessment and CE Mark, Technical Documentation, Definition of standards and GSPRs, and Assessment & Training.
Asphalion MedTech guides you through every step of the regulatory process, helping you navigate the complexities of international regulations with confidence and ease.
- Regulatory Roadmaps and Feasibility Assessments
for Europe & US. - EU & US Qualification & Classification.
- EU Certification Procedure assistance: CE Marking (including selection and management of communication with Notified Bodies and Technical Documentation submission).
- EU Technical Documentation preparation, compilation and maintenance (GSPRs, Risk Management activities, Clinical Evaluation , Performance Evaluation , Pre-Clinical support, Labelling, Post-Market Surveillance and other Technical Documentation core-parts preparation and/or evaluation).
- Support for EU country-specific regulatory requirements (including assistance with local Competent Authorities communication, product registration, facilities licenses, etc.).
- Support in EUDAMED registration (economic operators, UDI and devices).
- Assessment and training on MDR 2017/745 (Medical Device Regulations) and IVDR 2017/746 (In vitro Diagnostics Regulations).
- Definition, development and implementation of Quality Management System (QMS) according to ISO 13485, US 21 CFR 820 and MDSAP.
- Maintenance of QMS and annual audits programme (including ISO 13485, US 21 CFR 820, UK Medical Device Regulation and MDSAP).
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
ASPHALION’s experts have delivered solutions to over 1,500 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 10,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
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