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Improve the visibility and traceability of your data and get ready for EU MDR
Medical device companies are under constant pressure to maintain controls for regulatory compliance and quality assurance across every phase of the device life cycle.
To stay in control, systemic approaches are needed to provide transparency and early-stage error detection. This is especially true as products continue to become more personalized and complex, and the marketplace continues to become more global and competitive.
Through persistent traceability during the design phase, Medical Device PLM plays an important role in helping medical device manufacturers significantly reduce the time it takes to prove compliance with individual market regulations.
The traceability matrix from Minerva maps user needs, design inputs and outputs to their validation and verification results - all in an Excel-like format
It bridges the gap between fast-paced development, complex quality assurance, and cumbersome proof of compliance.
With Minerva’s knowledge of industry standards combined with unified Product Lifecycle Management (PLM) capabilities, Medical Device PLM help accelerate innovation for our medical customers, while streamlining quality assurance and automating proof of compliance.
To enable medical device companies to comply with regulatory requirements, Medical Device PLM provides an off-the-shelf solution driven by affordable and easy-to-deploy capabilities.
Our solution takes a holistic approach to compliance management that captures, manages, tracks and reports on a device's regulatory requirements as these evolve across a product lifecycle that includes an enterprise's design, manufacturing, test and service operations.
In the age of globalization many Medical Device companies are relying on external partners in order to get their products on the market faster. These external collaborations include design partners, manufacturing partners, software developers etc. This makes it extremely important for the company to be able to share data quickly and agree on designs, communicate and validate changes to the product quicker and with less complications.
Sharing data is always a challenge and is a tradeoff between security and flexibility. With the Medical Device PLM solution, it is possible to grant access to a set of requirements, parts, products and documents in an easier and more secure manner. Through the Permissions Manager, external users can be granted access to a certain set of data with the ability to revoke the access.
Being able to push the PLM system out to the extended supply chain, whilst still maintaining a high level of security in order to protect the intellectual property, is essential for the Medical Device industry.
Many Companies Are Still Exposed To A High Degree Of Non-Compliance:
As it is a regulation to have Device History Record (DHR) and Device Master Record (DMR) the typical industry practice is to design and print, meaning do the design and then print to paper and store in a binder.
A common industry practice is to make extensive use of spreadsheets to keep track and traceability of the user needs, design inputs and outputs along with their verification and validation plans along with the results.
In all cases, this is a manual process that is very labor intensive and error prone. Even if the product is correct, having data that is incomplete can trigger problems with audit. This is the landscape seen in many companies, with isolated file systems and spreadsheets.
The risk of data duplication, lack of traceability and error are quite high.
Medical Device PLM helps companies ensure regulatory compliance and work more effectively by providing a new approach to regulatory compliance, efficient document management, effective collaboration across disciplines and other mission-critical challenges.
Medical Device PLM has modules covering all important areas of the pre- and post-certification processes. By using a digital manufacturing platform that provides production, supplier and purchasing controls, FDA, MDR, ISO and other certificates can be obtained easier and faster.
Substituting paper records and handwritten signatures with electronic records and electronic signatures is a must for medical device manufacturers to achieve fast compliance with FDA 21 CFR Part 11.
The Medical Device PLM template provides an out-of-the-box solution so you can exceed the requirements:
- Meet FDA regulations for electronic records and signatures
- Achieve compliant document management and records storage
- Benefit from user/time stamping of records
- Leverage unalterable document history including baselines
- Improve management oversight with automated reports
- Accurate traceability for all artifacts throughout the entire lifecycle
- Intuitive interface increasing end user acceptance and productivity
- Out-of-the-box & easily configurable templates and processes
- Real-time monitoring and reporting of defects
- Fully traceable management of product complaints and adverse events
- Automated routing, approval and incorporated escalation for overdue tasks
Traditionally, to achieve FDA 21 CFR Part 820 compliance, you would labor through mountains of paper documents and disparate digital information, or invest in costly Document Management Systems.
With the Medical Device PLM you can create a Document History File (DHS) – including forensic level traceability – in minutes.
- Adhere to FDA Quality Systems Regulations
- Secure funding by quickly achieving FDA compliance
- Support the QA team to work with FDA 21 CFR Part 820
- Manage components from many different suppliers
- Easy maintenance of Design Controls and Design Documents
- Accurate traceability for all artifacts throughout the entire lifecycle
- Intuitive interface increasing end user acceptance and productivity
- Out-of-the-box & easily configurable templates and processes
- Real-time monitoring and reporting of defects
- Fully traceable management of product complaints and adverse events
- Automated routing, approval and incorporated escalation for overdue tasks
- Increased management oversight through advanced analytics and reports