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Posted by Sagitta Marwa on April 24, 2024 at 10:18pm 0 Comments 0 Likes
IZiel Healthcare are leading providers of engineering and regulatory services for MDD to MDR projects for medical device companies.IZiel helps you to obtain CE approvals for Class I, II & III Medical Devices, along with MDD to MDR transitions.
Added by Aniket Chaudhari on September 30, 2020 at 5:57am — No Comments
IZiel Healthcare are leading providers of engineering and regulatory services for MDD to MDR projects for medical device companies.IZiel helps you to obtain CE approvals for Class I, II & III Medical Devices, along with MDD to MDR transitions.
Added by Aniket Chaudhari on September 30, 2020 at 5:56am — No Comments
IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical device manufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.
Added by Aniket Chaudhari on September 23, 2020 at 8:29am — No Comments
IZiel Healthcare provides Process Validation for Medical Devices which includes IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), TMV (Test Method Validation) etc. Our robust Software Validation approach is aligned to IEC 62304 starting with requirements management alongwith risk management & traceability.
Added by Aniket Chaudhari on September 23, 2020 at 8:28am — No Comments
Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving…
ContinueAdded by Aniket Chaudhari on September 17, 2020 at 1:14am — No Comments
IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.
Added by Aniket Chaudhari on September 17, 2020 at 1:12am — No Comments
IZiel Healthcare are leading providers of engineering and regulatory services for MDD to MDR projects for medical device companies.IZiel helps you to obtain CE approvals for Class I, II & III Medical Devices, along with MDD to MDR transitions.
Added by Aniket Chaudhari on September 10, 2020 at 6:34am — No Comments
IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.
Added by Aniket Chaudhari on September 10, 2020 at 6:33am — No Comments
Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA…
ContinueAdded by Aniket Chaudhari on September 3, 2020 at 5:58am — No Comments
IZiel Healthcare are leading providers of engineering and regulatory services for MDD to MDR projects for medical device companies.IZiel helps you to obtain CE approvals for Class I, II & III Medical Devices, along with MDD to MDR transitions.
Added by Aniket Chaudhari on September 3, 2020 at 5:57am — No Comments
The medical device industry is presently facing massive reform like MDR (Medical device regulation) something never seen before. The massive changes will force many companies to do global reassessment and implement necessary changes to remain compliant. Even CE mark under MDD will also undergo major changes and your existing product will need re-certification. Clinical data and labelling also will need updating.
UDI…
Added by Aniket Chaudhari on September 3, 2020 at 3:00am — No Comments
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