At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.
Efficient and Compliant Design Control Documentation
Aligned’s highly experienced team will assist you in developing and optimizing your Design Control structure, associated templates and processes.
We assist you in optimizing your:
- Design History File (DHF)
- Technical File (TF)
- Risk Analysis
- Design Reviews
- Verification & Validation
Risk Management for Medical Devices
Risk Management is the central aspect in medical device development. ISO 14971 is the essential standard for manufacturers of medical devices seeking regulatory approval in all major markets.
We assist you in setting up and conduct:
- Medical Device Design Risk Assessments according to ISO 14971
- Software Risk Assessments for complicance with IEC 62304
- Usability Risk Assessments for compliance with IEC 62366
- Cybersecurity Risk Assessments in line with FDA's recommendations
Implementation of International Medical Device Standards
Using international, harmonized standards in your development process is one the most efficient ways to achive regultory compliance. The practical implementation can be easier said than done.
We assist you in implementing standards such as:
- ISO 14971 – Risk Management for Medical Devices
- IEC 62304 – Medical Device Software
- IEC 62366 - Usability for Medical Devices
- IEC 82304 – Health Software
Medical Device Computer Software Validation
We ensure that your computer system gets validated according to industry standards. We provide documented proof of the accuracy, reliability and consistent performance of your system.
Our Computer Software Validation services include:
- Categorization and planning according to GAMP 5
- IQ / OQ / PQ testing by industry experts
- Full Computer System Validation documentation package
- FDA 21 CFR Part 11 compliance assessments