Personal protective equipment enables user protection against hazards at work, at home or at leisure. There are mechanisms in the professional setting to achieve what the Union see...
Post Market Performance Follow-up (PMPF) refers to proactive method of collecting and evaluating performance and relevant scientific data generated during the use of device already...
PMCF is one of the segments of Post Market Surveillance and it is a continuous process that updates the quality management system with focus to areas like clinical evaluation, and ...
As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results ...
As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results ...
If manufacturers want to place your devices in European Market, they must prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV 2.7.1. rev...
The MDR (Annex XIV, Part A) establishes that, in order to demonstrate equivalence in relation to other devices, three characteristics must be considered when demonstrating equivale...
Literature Search is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your device. It’s a ...
A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDR article 61 and Annex XIV Part A.
Our CER writers are involved in a comprehensive review of clinical data derived from clinical settings, literature, state of art for assessing appropriate device safety and perform...
he summary of safety and clinical performance (SSCP) shall be laid out with an objective of it being easy for the intended user to interpret and, if relevant, to the patient. It sh...
LOAS is a document that provides requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and servi...
We at Maven, help you determine which of the new ‘safety and performance requirements’ will be considered as applicable, and to ensure an appropriate rationale for requirements...
The concept of Medical Device and In-Vitro Diagnostic Device Risk Management is complex because of the diversity of collaborators including medical practitioners, the organizations...
The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and c...
Medical Device CE Marking Service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all clas...
Display this QR code on your business cards, brochures, posters, or exhibition booths. Potential clients and partners can quickly scan it with their smartphones to view your business information on the spot.
Listed a new item.
Personal Protective Equipment CE Marking
Personal protective equipment enables user protection against hazards at work, at home or at leisure. There are mechanisms in the professional setting to achieve what the Union see...Listed a new item.
Ce Medical Device Software
If you are willing to certify your SaMD – Software as a Medical Device, Maven is all prepped to guide you!Listed a new item.
Post Market Performance Follow-up
Post Market Performance Follow-up (PMPF) refers to proactive method of collecting and evaluating performance and relevant scientific data generated during the use of device already...Listed a new item.
Post Market Clinical Follow-up
PMCF is one of the segments of Post Market Surveillance and it is a continuous process that updates the quality management system with focus to areas like clinical evaluation, and ...Listed a new item.
Periodic safety update report
As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results ...Listed a new item.
Post Marketing Surveillance report (PMSR)
As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results ...Listed a new item.
Clinical Evaluation Report
If manufacturers want to place your devices in European Market, they must prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV 2.7.1. rev...Listed a new item.
Demonstration Of Equivalence
The MDR (Annex XIV, Part A) establishes that, in order to demonstrate equivalence in relation to other devices, three characteristics must be considered when demonstrating equivale...Listed a new item.
Literature Search Protocol & Report
Literature Search is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your device. It’s a ...Listed a new item.
Clinical Evaluation Plan
A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDR article 61 and Annex XIV Part A.Listed a new item.
Clinical Evaluation
Our CER writers are involved in a comprehensive review of clinical data derived from clinical settings, literature, state of art for assessing appropriate device safety and perform...Listed a new item.
Medical Device Testing
As we rely on the proficiency of the medical device to perform as intended, the slightest deficiency in the medical device can provide tragic results.Listed a new item.
Summary of safety and clinical performance (SSCP)
he summary of safety and clinical performance (SSCP) shall be laid out with an objective of it being easy for the intended user to interpret and, if relevant, to the patient. It sh...Listed a new item.
List of Applicable standard (LOAS)/Quality Standar
LOAS is a document that provides requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and servi...Listed a new item.
General Safety And Performance Requirement
We at Maven, help you determine which of the new ‘safety and performance requirements’ will be considered as applicable, and to ensure an appropriate rationale for requirements...Listed a new item.
Risk Management
The concept of Medical Device and In-Vitro Diagnostic Device Risk Management is complex because of the diversity of collaborators including medical practitioners, the organizations...Listed a new item.
Medical Device Technical File
The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and c...Listed a new item.
CE For Medical Device
Medical Device CE Marking Service covering reusable medical devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all clas...