FDA: Complaint Handling
A high number of complaints is not necessarily indicative of poor device quality. There could be many reasons for large number of complaints. Customers may Read More »
Importance of standards conformance is undeniable, unfortunately, so is the complexity of becoming compliant. Conformity Technology provides complete compliance solutions, so you can focus on building great products…
Don’t let the complexity of conformance with standards such as ISO-9001 hold you back! Let us help you with your conformance needs so you can focus on solving world problems…
With over 30 years of experience, we are the experts when it comes to conformance. Contact us to find out how our customized solutions can help you with your conformance needs.
Complex standards that hard to understand and follow
Companies need to focus on their core task: product development
Companies need a partner with a track record that they can trust
Existing solutions have prohibitive costs
Conformance needs to be maintained and recertification is required on a periodic basis
Conformity is with you every step of the way. It provide you the best solutions of your problems, we took care of the core issues (Identity, Maintain, Prepare, Acquire). We are dedicated to provide best of the elite alternatives to overcome those issues and make things more feasible for our users.
Identify certification needs
Develop processes, documents etc. for compliance
Help with every step of compliance audit
Follow changes in standards and update accordingly to maintain certification
Conformity is with you every step of the way. It provide you the best solutions of your problems, we took care of the core issues (Identity, Maintain, Prepare, Acquire). We are dedicated to provide best of the elite alternatives to overcome those issues and make things more feasible for our users.
Identify certification needs
Develop processes, documents etc. for compliance
Help with every step of compliance audit
Follow changes in standards and update accordingly to maintain certification
Conformity is with you every step of the way. It provide you the best solutions of your problems, we took care of the core issues (Identity, Maintain, Prepare, Acquire). We are dedicated to provide best of the elite alternatives to overcome those issues and make things more feasible for our users.
CONFORMITY SOLUTION
Identify certification needs of our client to help them to succeed in long run. We work for:
CONFORMITY SOLUTION
Develop processes, documents etc. for compliance.
CONFORMITY SOLUTION
Help with every step of compliance audit.
CONFORMITY SOLUTION
Follow changes in standards and update accordingly to maintain certification.
A high number of complaints is not necessarily indicative of poor device quality. There could be many reasons for large number of complaints. Customers may Read More »
The EU Medical Device Regulation (MDR) requires manufacturers to have available at least one person, within their organization, responsible for Regulatory Compliance. That person is known Read More »
A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the Read More »
When companies begin their quest for an ISO 9001 or ISO 13485 certification, they often wonder how many procedures do they need to satisfy certification Read More »
If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Read More »
Continuing with the Quality Management discussion that I started in my last blog, let’s talk about how changes may occur within a predefined process. Perhaps Read More »
A high number of complaints is not necessarily indicative of poor device quality. There could be many reasons for large number of complaints. Customers may be dissatisfied when they have expectations beyond the capability of what a device can do. There could be a requirements mismatch. A manufacturer may have return policies that inadvertently encourage […]
The EU Medical Device Regulation (MDR) requires manufacturers to have available at least one person, within their organization, responsible for Regulatory Compliance. That person is known as Person Responsible for Regulatory Compliance or PRRC (we love acronyms!). For a Micro and/or small enterprise, the PPRC does not need to be within the manufacturer’s organization but must […]
A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. A Clinical Evaluation is required for all medical devices to be marketed in Europe. Alternative treatment options including no treatment should be […]