Acera is proud to announce they are joining the Medtech Resource Alliance (MRA), a distinguished association of organizations, which specialize [...]
Acera Innovation has launched their upgraded website which includes….
Acera has upgraded their marketing web site, leveraging Web2.0 technology to provide more information about Acera’s Pathway product.
Who uses Pathway?
Anyone on your team that needs to create, review or approve deliverables as part of the product development or regulatory compliance process. Pathway combines product development / product lifecycle management, project management & collaboration and the quality management system into one web-based, SaaS platform for your medical device team.
What is Pathway?
A simpler way of managing all aspects of the product development and regulatory compliance process, specifically designed for medical device manufacturers.
I’ve been using MS-Office templates for 100 years – why should I change now?
You don’t have to. Pathway lets you “vault” your MS documents (or any file type) as file attachments to any deliverable in Pathway. But this is optional. You can also build deliverables w/o file attachments. Microsoft Office has been a great tool but with increased audits and emphasis on linkages between deliverables, the complexity of the projects and the emergence of virtual teams, using a web based tool for a single view of the project, product & QMS information can make it much easier for everyone involved in the process.
Can Acera’s staff see my stuff?
No one from Acera, or anyone else has visibility to your deliverables, unless you explicitly give access to them as part of your team.
How does Pathway simplify my life?
Acera’s Pathway puts all the deliverables in one place, leveraging the power of Web2.0 technology to improve the project transparency and line item linkages to make it easier for everyone on the team to see the progress towards a common goal.
I have a QMS in place today and don’t want to replace it, can I just buy the Product Development part of Acera?
Acera’s Pathway is a flexible tool that supports the way you want to work, you can use all or some of the parts of Pathway, whatever works best for you.
Does Pathway replace Solidworks or ProEngineer or any of my other CAD tools?
No. Pathway supports the integration of files from different tools such as CAD into a structured product development process and as part of a set of deliverables such as specifications.
What development methodology does Pathway support?
Pathway supports any methodology you want to use through a flexible project plan and the deliverables defined by your methodology.
Does Pathway have a Design History View?
The information for your product’s design history file is fully contained in Pathway. It is a compilation of the deliverables such as requirements, risk management file, specifications, DMR, protocols and reports) linked to your product, as well as the project plan for the product design & development and the design and phase reviews held per as part of the project.
Quality Management Questions
Does Pathway come with a Quality Management System (QMS)?
Pathway has Standard Operating Procedures (SOPs) and Work Instructions (WIs) specifically drafted to both comply with applicable regulations and standards (ISO 13485:2003 and FDA’s QSR) and also describe use of Pathway for supporting your company’s QMS. A QMS is made up of people, procedures and practices which are compliant to the applicable regulations the QMS is intended to support. Pathway provides an infrastructure for your company’s QMS in a highly visible, structured and collaborative environment specifically designed for medical device QMS support.
Does Pathway replace my existing Quality Management System?
Pathway can house your existing QMS in a paperless, highly visible and collaborative environment, making finding information and staying compliant easier.
How Pathway support Change Control per FDA’s QSR and ISO 13485 ?
Pathway allows you to group single or multiple deliverables together into a single Change Order and specify the order in which people sign off to approve the deliverables and the background information that is part of Change Order. Pathway maintains the revision history of each deliverable allowing you to view previous versions.
Is the Pathway software validated?
According to FDA QSR, and ISO 13485:2003:
Computers or automated data processing systems that are part of production or the QMS shall be validated for their intended use according to an established protocol, prior to initial use. Changes to software are validated before approval and issuance. Validations results are documented.
Although Pathway is tested prior to each build release, no formal software validation has been completed yet as part of the Limited Market Release of Pathway. Acera plans for internal software validation are Q4 2010, subsequently the validation protocol and report (results) will be available to Acera customers. Support is available from Acera for our customers own validation of Pathway per their intended use.
We are a small medical device company – do we really need a system like this?
Yes. Without a system like this, you’ll find your team trying to manage the product development, project timelines/deliverables and Quality Management System by paper means which is slow, inefficient and wrought with problems for collaboration beyond four walls, or trying to build their own system (wouldn’t you rather focus on the medical device?) or buy buying piecemeal solutions for parts of what Pathway provides. With Pathway in place your team can focus on value-added activities.
I have an audit coming up/just finished will Acera help me prepare for/recover from my audit?
Acera can provide consulting services to help you prepare for your audits, or react to findings from quality system audits (such as Notified Body, FDA, and customer audits). Acera’s team is comprised of numerous medical device quality system experts with CQA (American Society for Quality’s Certified Quality Auditor) certification.
Does Pathway submit my 510(k) for the FDA?
Electronic submissions are not currently implemented in Pathway. We will be adding it to Pathway in the near future. Currently the regulatory submission can be a created as a report deliverable or a business deliverable. The report route would allow revision control of the submission (i.e. initial submission and change which might arise due to questions from the regulatory body).
Does Pathway tell me all the things I need to do to submit my 510(k)?
The link to the FDA’s guideline on determining whether your device requires at 510(k) premarket notification prior to marketing your device, and their guideline on the contents of a 510(k) is provided with all new accounts as part of the base reference library that includes typical External Documents used by a medical device company. The starter references include a listing of some of the general FDA consensus standards, EU harmonized standards, FDA regulations and guidelines, Europe’s Medical Device Directive (MDD), and GHTF guidelines.
Do you support floating licenses?
Pathway does not currently support floating licenses. Due to our rigorous document control and the need for all members of a collaborative team be able to participate in the product development and compliance process without regard for how many users you may have at any particular point in time.
Can I get ready only access?
Due to the collaborative nature of the product development process and the need for rigorous document control and tracking Pathway does not currently support read only access.
Do I have to pay for my contractors too?
All authorized users of the system are required to have licenses, this may include employees or part time contractors.
How do I change the number of seats?
Acera can increase or decrease the number of users with a phone call, simply call us and we will increase, or decrease, the authorized number of users
What forms of payment does Acera accept?
Acera will invoice you monthly and you can pay with credit card, check or PO.