ISO 13485

Medical Devices- Quality Management System

• the international standard recognized for medical device regulations around the world.
• the most accepted standard worldwide for manufacturers of medical devices (e.g. USA, Japan, Canada, EU).
• This provides the list of requirements for a quality management system wherein a company needs to show its capability to supply medical devices and related services that are in conformance to relevant requirements both regulatory and customer related.
• This standard is applicable to companies that are involve with medical devices wheather in the early stages such as design and development, production, storage and distribution or even after selling such as installation or servicing of a medical device. This also applies to design and development or provision of associated activities such as technical support.

5 Easy Steps to ISO 13485 Certification

• Fill in the enquiry form and we will conduct a free gap analysis based on ISO 13485 and your
  organization requirement and we will provide you a quote.
• Upon agreement to quotation, a scheduled trainings will follow together with documentation requirements for certification.
• Once you completed the trainings and documentations, a pre-audit will be conducted.
• Final audit and reports will be performed by Certification Auditors. Assistance will be given to ensure you close all non conformance records.
• Once your organization is 100% compliant to ISO 13485, a certificate will be issued. And once you are satisfied with our service, we expect to receive your payment.

Benefits

• Evidence of adherence to legal and regulatory or contractual requirements
• Minimize and manage risks
• Emphasize competence
• Error prevention instead of error correction
• Improved performance quality
• Customer employee satisfaction
• Transparency and clarity of internal processes
• Time and cost savings

Cost

The cost of certification is guaranteed at its best. Payment is required once certificate has been released. Once you start the process, a Letter of Commitment will be provided and be assigned to our account executive that will hasten and monitor your progress. This method had already helped many companies to be certified within a minimal and considerable time.

Why Choose Us