Technical Files
Get all the documentation ready for your Medical Device to be submited for regulatory compliants. Obtain your CE marking
Risk Assessment for the development of Medical devices
Our risk assessment based on ISO 14971 will highlight and document all the risk related to your medical device and have it ready to get the CE marking
SME in pharmaceutical formulation
Consult an expert in pharmaceutical formulation and analythical chemistry for pharmaceutical products
Let's understand the clinical risk of your device and literature review wiht our Clinical Evaluation Report
Quality System for Medical device ISO 13485
Complaint Management
Non Conformancies and CAPA Reports
Change Control Planning
KPI Identification and tracking system
Audits
Supplier Management
SME in dressing for wound care management
Consult an expert in adhesive, product design, tensile strenght and more
Technical Support for formulation and analysis of Pharmaceutical Product
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Get help on R&D projects for pharmaceutical formulation and analysis
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Review of technical documentation and laboratory requirements
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Expert in HPLC and analytical chemistry
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Data Analysis
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Reports for licence variation