MEC-ABC Medical Care and Product Development
1 - 10 employees
Founded 2016
đ Compliance
đ¤ B2B
Compliance ⢠B2B
MEC-ABC Medical Care and Product Development is a Germany-based regulatory consulting firm specializing in clinical evaluation and regulatory compliance for medical devices under the EU Medical Device Regulation (MDR 2017/745). The company supports manufacturers with Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), PMCF and PMS strategies, technical documentation, claim management, deficiency analyses, and clinical study planning to achieve CE conformity and streamline Notified Body interactions. They also offer educational resources (whitepapers, minikurs, consultation hours) and template packages to help clients reduce time and cost in the certification process.
Advanced Training in International Regulatory Affairs, Medical Writing
đĽ 2 hours ago
đŁď¸đŠđŞ German Required
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MEC-ABC Medical Care and Product Development
1 - 10 employees
Founded 2016
đ Compliance
đ¤ B2B
Compliance ⢠B2B
MEC-ABC Medical Care and Product Development is a Germany-based regulatory consulting firm specializing in clinical evaluation and regulatory compliance for medical devices under the EU Medical Device Regulation (MDR 2017/745). The company supports manufacturers with Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), PMCF and PMS strategies, technical documentation, claim management, deficiency analyses, and clinical study planning to achieve CE conformity and streamline Notified Body interactions. They also offer educational resources (whitepapers, minikurs, consultation hours) and template packages to help clients reduce time and cost in the certification process.
đ Description
⢠Practical creation of medical and scientific texts ⢠Drafting medical and regulatory documents ⢠Individual feedback from experienced instructors
đŻ Requirements
⢠University degree in life sciences, engineering, informatics, etc., or several years of professional experience ⢠German and English at B2 level (language skills are required)
đď¸ Benefits
⢠Career and one-to-one coaching ⢠Certificate of participation covering all content ⢠Work samples you can present on request ⢠Individual support and personal coaching ⢠Practice-oriented course design with a strong training focus
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