Getting your Medical Device to Market
Need help with getting your Medical Device to market? QualMed is focused on the medical device industry, seeking to provide the best service to get you there. We will support you from the earliest pre-revenue organization to medical a device company. We have a close working relationship with Health Canada and FDA if any issue may arise.
Developing and Maintaining QMS
Let's face it, Quality Systems can be an arduous task and maybe something that you don't want to take on. Or maybe you already have an existing system and are looking to improve it. QualMed can develop a plan that will make this process as easy and as painless as possible.
Audit, Compliance, Regulations and Standards
QualMed tailors all needs through audits, compliance, regulations and standards specifically for life science and medical device industry.
Provide Client-Specific Training
QualMed can deliver in-depth competence-based training on a number of topics:
Need help with getting your Medical Device to market? QualMed is focused on the medical device industry, seeking to provide the best service to get you there. We will support you from the earliest pre-revenue organization to medical a device company. We have a close working relationship with Health Canada and FDA if any issue may arise.
Developing and Maintaining QMS
Let's face it, Quality Systems can be an arduous task and maybe something that you don't want to take on. Or maybe you already have an existing system and are looking to improve it. QualMed can develop a plan that will make this process as easy and as painless as possible.
Audit, Compliance, Regulations and Standards
QualMed tailors all needs through audits, compliance, regulations and standards specifically for life science and medical device industry.
Provide Client-Specific Training
QualMed can deliver in-depth competence-based training on a number of topics:
- US FDA Quality System Regulation - 21 CFR Part 820
- Health Canada Medical Device Regulation - SOR 98-282
- ISO 13485:2016 - Quality management systems -- Requirements for regulatory purposes
- IEC 62304:2006 - Medical device software — Software life cycle processes
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- ISO 19011:2019 - Guidelines for Auditing Management Systems