𝐈𝐧𝐭𝐫𝐨𝐝𝐮𝐜𝐢𝐧𝐠 𝐎𝐮𝐫 𝐍𝐞𝐰 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 (𝐏𝐌𝐒) 𝐑𝐞𝐩𝐨𝐫𝐭𝐢𝐧𝐠 𝐒𝐮𝐩𝐩𝐨𝐫𝐭 𝐒𝐞𝐫𝐯𝐢𝐜𝐞
International Associates Limited is excited to announce our latest offering: Post-Market Surveillance (PMS) Reports. Ensuring compliance with ISO 13485:2016 and regulatory requirements such as UK MDR, EU MDR, and FDA QSR has never been easier.
𝐖𝐡𝐲 𝐢𝐬 𝐏𝐌𝐒 𝐢𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭?
𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: All medical devices must have a PMS plan, and regular PMS reports are crucial for maintaining compliance.
𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐈𝐧𝐩𝐮𝐭: Our PMS reports consider Field Safety Notices (FSNs), Field Safety Corrective Actions (FSCAs), new clinical literature, material reports, and safety bulletins.
𝐇𝐨𝐰 𝐜𝐚𝐧 𝐰𝐞 𝐡𝐞𝐥𝐩 𝐲𝐨𝐮?
𝐂𝐮𝐬𝐭𝐨𝐦 𝐏𝐌𝐒 𝐏𝐥𝐚𝐧𝐬: Don’t have a PMS plan? We can create one tailored to your needs.
𝐃𝐞𝐭𝐚𝐢𝐥𝐞𝐝 𝐑𝐞𝐩𝐨𝐫𝐭𝐬: Provide us with your device details, and we’ll compile a comprehensive PMS report for you.
Ensure your devices meet all necessary standards with our expert support. Contact us today to discuss.
enquiry@ia-uk.com | www.ia-uk.com
Effortless and Effective PMS Reporting Solutions
#InternationalAssociates #ISO13485 #Audit #Compliance #Healthcare #Health #MedicalDevices #Manufacturing #Technology #Tech #QualityAssurance #SafetyFirst #ContinuousImprovement
Author: m-coles
Published Date: June 18, 2024