Premium Organizational Management Services

1. Premium Organizational Management Services www.mavenprofserv.com

2. Overview Introduction Anewbeginningofcontinualcompliance TheSolution-LeaveittotheExperts!

3. Introduction External solutions that can assist you in regulatory submissions for your certification and registration activities are readily available through regulatory consultancies They not only free you from your regulatory effort but make the process so much faster and hassle-free without having to invest in upgrading your resources with the evolving regulations and requirements. But do you really think that is enough?

4. Doyouthinksuccessfullygettingcertificationsand registrationistheendgoalofregulatorycompliance?Doyou think,it is a smooth journey ahead by merely havinga certificate in hand? What do you think should be the next majorobjectiveinyourregulatoryjourney?

5. Anewbeginningofcontinualcompliance Being awarded regulatory certification is nothing but the start of a whole new journey of demonstrating continual compliancetoretainsuchcertificatesandbreezethrough yoursurveillance. Thingstotakecarepostcertification:

6. Hire resources to maintain your technical documentation which includes updating these documents with the revision in standards, annual updates with the post-market surveillance data, and keep them prepared for yearly audits. Have resources in place to maintain your quality management system and simultaneously upgrade your systems and processes to reduce product and process non-conformities thereby increasing the yield and reducing rejections.

7. Postreceivingthecertificate,onestartsexpanding their business to other countries and hence needs to initiatecountryregistrationprocesseswhichhave differentrequirementsindifferentcountriesandhence manpower shallbe needed to continuously process registration in different countries. shall be needed to continuouslyprocessregistrationindifferentcountries. Preparationforsurveillanceaudits,representingand answeringtotheauditors,andclosinganynon- conformancesthatareobservedduringsuchaudits.

8. Keepyourresourcestrainedandbecontinuously awareofrevisionsinstandards,guidelines,and changingrequirements. EnsurePost-marketdataisbeingcollected adequatelyandanalyzedtoidentifyanyemergingrisks or further scope of improvement in the product based oncollectedcomplaintsorfeedback. Constantlylookforadverseevents,andvigilance activitieshappeningacrosstheglobewithsimilar devicesandtakeanypreventiveactionifnecessary.

9. The list of such necessary actions to be taken is endless andhavinganin-houseregulatorydepartmentwitha minimum of 2-3 full-time employees completely dedicated to RA functions becomes unavoidable and it is needless to saythattheseemployeesmustbekeptupdatedand trained at all point and we can still not be sure if our efforts areenough.

10. TheSolution-LeaveittotheExperts! TakeapremiumadvantageofMAVEN'sPremium OrganisationalManagementServices.Oneofitskindandfirst time in India, a consultancy that is constantly keeping an eye ongaps inmedical device manufacturingindustry and is continuously engaged in curating solutions to bridge this gap andhelpmanufacturers'competeonagloballevelwith improved processes and systems makingeveryday within theorganisationanauditcompliantday.

11. These services are only for clients who are completely invested in making their plant highly compliant and are readytoconsiderregulatorycomplianceanimportant parameterfortheirorganisationalsuccessandmake necessaryresourcesavailabletoachievethesame.

12. Contact Us https://mavenprofserv.com/premium-organizational- management-services/ business@mavenprofserv.com enquiry@mavenprofserv.com