ISO 13485 Quality Program is a requirement and a preference for many medical device manufacturers and distributors of class 1, 2 3 or 4 medical device products. Development and implementation of ISO 13485 can help in meeting many of regulatory guidelines required by Health Canada CMDCAS and FDA in the USA.
Polymerics can provide professional consulting services to your organization in achieving its ISO 13485 registration. Our services include following services:
- (1) ISO 13485 Medical Device Quality Program development. This includes review and discussion of your products and services and developing a quality program manual with policy, procedures and relevant control documents.
- (2) Program Implementation. This would include implementation of developed program and generation of quality records . Thus a documented evidence is produced to show that implemented program is followed by all at the facility.
- (3) Employee Training. This would include providing employee training sessions for ISO 13485 program and helping employees in day to day documentation.
- (4) Internal Auditing Services. We conduct internal audits of the program to ensure that it meets relevant requirements. This would include verifications and any validations in place.
- (5) We can assist in arranging registration audit of your company to ISO 13485 standard. We would attend your registration audit and discuss any issues or NCR's raised your registration auditor. Furthermore, we would help to rectify any NCR's with corrective actions to a satisfactory and successful conclusion. We would stay with you till your company achieves its ISO 13485 registration.
If your company is already ISO 9001-2008 Registered, you may consider our program maintenance services.
Program Maintenance Services - We can provide consulting services to help maintain your quality program. I many cases your employees may be busy in other tasks, or you simply want a qualified consultant to come in every so often and help out in your program. Our consultants can conduct your internal auditing, provide group training sessions of employees, update quality manuals and write additional procedures as needed. (We also provide technical report writing services). Contact us for a no obligation initial discussion.
Requirements of ISO 13485 Medical Device Quality Program
This section is under development - additional info would be included.
Call us to discuss your requirements.
Phone: (905) 608-9177
Email: info@polymerics.ca