IZiel Group
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IZiel Group posted a blog post

Medical Device Software Validation

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical…See More
Tuesday
IZiel Group posted a blog post

Medical Device Software Validation

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical…See More
Mar 31
IZiel Group posted a blog post

Medical Device Software Validation

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical…See More
Mar 23
IZiel Group posted a blog post

IQ OQ PQ Medical Devices

IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.https://iziel.com/what-is-iq-oq-pq-medical-devices/See More
Mar 18
IZiel Group posted a blog post

Medical Device Software Validation

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical…See More
Mar 12
IZiel Group posted blog posts
Mar 5
IZiel Group posted a blog post

MDD to MDR

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.See More
Feb 26
IZiel Group posted blog posts
Feb 19
IZiel Group posted a blog post

MDD to MDR

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.https://iziel.com/mdd-to-mdr/See More
Feb 13
IZiel Group posted blog posts
Feb 6
IZiel Group posted a blog post

Process Validation for Medical Devices

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.See More
Jan 29
IZiel Group posted a blog post

MDD to MDR

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.See More
Jan 24
IZiel Group posted a blog post

MDD to MDR

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.See More
Jan 17
IZiel Group posted a blog post

Regulatory Remediation Services

IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) and resolve queries, if any, from USFDA.…See More
Jan 3
IZiel Group posted a blog post

Medical Device Software Validation

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical…See More
Dec 27, 2019
IZiel Group posted a blog post

FDA Remediation Consultants

Remediation Consultants at IZiel implement best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries. IZiel provides expert solutions to remediate 483 observations and warning letters. IZiel teamworks with medical device companies across the globe to achieve regulatory andstandard compliance.https://iziel.com/fda-remediation-consultants/See More
Dec 20, 2019

IZiel Group's Blog

Medical Device Software Validation

Posted on April 7, 2020 at 3:27am 0 Comments

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for…

Continue

Medical Device Software Validation

Posted on March 31, 2020 at 1:03am 0 Comments

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for…

Continue

Medical Device Software Validation

Posted on March 23, 2020 at 2:59am 0 Comments

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for…

Continue

IQ OQ PQ Medical Devices

Posted on March 18, 2020 at 5:39am 0 Comments

IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.

https://iziel.com/what-is-iq-oq-pq-medical-devices/

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