In the rapidly evolving medical device industry, ensuring the ongoing safety and performance of your products is paramount. Our consultancy services for Post-Market Surveillance (PMS) are designed to help you navigate the complexities of the different Regulations with confidence and ease.
Here’s Why Partnering with us is the Best Decision for Your Business:
Ensuring Safety, Compliance, and Performance
At Sushvin, we provide comprehensive consultancy services for Post-Market Surveillance (PMS) of medical devices. Our expert team is dedicated to ensuring the ongoing safety, compliance, and performance of your products in the market. Our services encompass essential components of PMS, including Post-Market Clinical Follow-up (PMCF), Post-Market performance Follow-up (PMPF) and Periodic Safety Update Reports (PSUR).
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Our PMS- Post-Market Surveillance Consultancy Services
What is Post-Market Surveillance?
Post-Market Surveillance is a systematic process that involves the ongoing collection, analysis, and evaluation of data related to a medical device’s performance after it has been approved for use. This critical phase helps identify any potential risks, adverse events, or trends, allowing for timely interventions and product improvements.
We provide expert advice on the regulatory requirements for PMS, ensuring your processes align with the latest standards set by organizations like the UK MHRA, EMA and US FDA.
Our team assists in developing effective data collection methods, including surveys, complaints, proactive and reactive user feedback, sales data, vigilance database searches, trends and clinical studies including scientific literature and database searches, to gather valuable insights on your device’s performance.
We conduct thorough risk assessments to identify potential safety concerns and develop strategies for mitigating risks throughout the product lifecycle.
We help prepare comprehensive PMS reports that summarize findings and provide actionable recommendations, ensuring clear communication with regulatory authorities.
Our consultancy services include ongoing monitoring and evaluation of your products to ensure that any emerging issues are promptly addressed, maintaining the highest standards of safety and efficacy.
At Sushvin, we specialize in Vigilance Reporting services to help medical device manufacturers monitor, evaluate, and report adverse events in compliance with regulatory requirements. Our expert team ensures timely submission of reports to authorities, risk assessment, and the development of corrective actions, all aimed at enhancing patient safety and maintaining regulatory compliance. Partner with us to safeguard your products and streamline your vigilance processes effectively.
Our PMCF- Post-Market Clinical Follow-up Services
What is PMCF?
Post-Market Clinical Follow-up (PMCF) is a crucial aspect of Post-Market Surveillance (PMS). It involves the systematic collection and evaluation of clinical data after a medical device has been introduced to the market. PMCF aims to confirm the safety and performance of the device in real-world settings and to identify any potential risks or adverse effects that may arise during its use.
We provide comprehensive guidance on regulatory requirements related to PMCF, ensuring your studies align with the latest standards set by authorities such as the UK MHRA, EMA and US FDA.
Our team works with you to design robust PMCF studies tailored to your device and target population. We help define study objectives, methodologies, and endpoints to ensure meaningful data collection.
We assist in developing effective data collection strategies, utilizing surveys, clinical evaluations, scientific literature, registry studies, clinical trials, and user feedback to gather valuable insights into your device’s performance and safety.
The process involves continuous data analysis to ensure the ongoing safety and performance of medical devices including trend analysis, root cause analysis.
Our experts conduct thorough risk assessments, identifying potential safety concerns and formulating strategies to mitigate risks throughout the device’s lifecycle.
We prepare comprehensive PMCF reports that summarize findings, analyse data, and provide actionable recommendations, ensuring clear communication with regulatory authorities and stakeholders. The report includes Summary of Findings, CAPA (Corrective and Preventive Actions) and Updates to Clinical Evaluation and Risk Management.
Our PSUR- Periodic Safety Update Report Services
What is a PSUR?
A Periodic Safety Update Report (PSUR) is a critical document that summarizes the safety and efficacy of a medical device based on data collected during its lifecycle. It provides regulatory authorities with essential information regarding the benefit-risk profile of the device, ensuring that any emerging safety concerns are promptly addressed.
We provide expert guidance on the regulatory requirements for PSURs, ensuring that your reports align with the latest standards from agencies such as the UK MHRA, EMA and US FDA.
Our team assists in gathering and analysing safety and efficacy data from various sources, including post-market surveillance, clinical studies, and user feedback, to create a comprehensive overview of your device’s performance.
We prepare detailed PSURs that summarize findings, analyse trends, and assess the risk-benefit profile of your medical device, ensuring clarity and transparency for regulatory submissions.
Our consultancy includes thorough evaluations of any identified risks, providing actionable recommendations for risk mitigation and ensuring ongoing compliance with safety standards.
Ensure the ongoing safety and compliance of your medical devices with our expert consultancy services for Post-market Surveillance. Contact Sushvin today to learn how we can support your PMS efforts and navigate the complexities of regulatory compliance!
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Ensure a successful entry into the market with our comprehensive Regulatory Strategy and Commercialisation consultancy services. Contact Sushvin today to learn how we can support your journey and help you navigate the complexities of regulatory compliance and market access!
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