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Forum Replies Created

RE: Consultants in the Medical Device Industry

I currently work as a Technical Writer for a company that offers healthcare technology solutions such as biomedical equipment rentals, technology management, as well as technical service for hospitals...

In forum Consultants and Legal Basics

5 years ago
RE: Advice before signing an NDA

I have signed many NDA’s and my advice is to read the entire document carefully prior to signing. After signing, I strongly advise asking exactly what details are bound by the NDA. Sometimes an NDA co...

In forum Consultants and Legal Basics

5 years ago
RE: Factors to consider when executing the NDA

My company recently acquired a contract which would increase our business by 35%. My department was reallocated to help build the infrastructure for the company to successfully operate this new busine...

In forum Consultants and Legal Basics

5 years ago
RE: Your Organizational prference; but why?

I would prefer to work for a company that employs a functional organizational structure because it seems to be the most intuitive form of corporate hierarchy. I currently work as a technician for a co...

In forum Organizational Development in Device Companies

5 years ago
RE: Upper vs Middle Management.

In order to succeed in an upper management position, it is important to understand the industry. In my opinion, the best way to fully understand an industry is to work from the ground up. I had the pl...

In forum Organizational Development in Device Companies

5 years ago
RE: Discussion Topic: Your organizational type

I currently work for a healthcare technology solutions company that provides rental service, inventory management, and technical service for medical equipment in hospitals throughout the country. The ...

In forum Organizational Development in Device Companies

5 years ago
RE: FMEA Reviews and Brainstorming

Brainstorming is a fantastic method to quickly generate a list of potential risks, however sometimes a brainstorming session seems to hit a limit. I have found from my own experience that introducing ...

In forum Risk Analysis for Medical Devices

5 years ago
RE: Risk Management Tools

When thinking back upon my previous projects from academia, I realize my project teams always followed the same process when performing risk management. We would initially get together as a team and h...

In forum Risk Analysis for Medical Devices

5 years ago
RE: Benefits of post-market surveillance

Another benefit of post-market surveillance is determining whether preventive actions from risk management processes have been effective. This can be done by simply reviewing the risk register along w...

In forum Risk Analysis for Medical Devices

5 years ago
RE: Design Control Experience

My closest experience working with design controls was when I developed a surgical stapler testing apparatus for my undergraduate senior year capstone project. My team and I implemented the twelve-ste...

In forum Introduction to Design Controls

5 years ago
RE: Important Part of DDP

Each part of the Design Development Plan has its own importance however the scope management plan is especially important because it sets boundaries for the project. A project can have excellent commu...

In forum Introduction to Design Controls

5 years ago
RE: examples of controlled device changes

After a device has been released it may experience common failures that lead to a recall. When a recall is issued, the manufacturer typically investigates the failure and develops a recall remediation...

In forum Introduction to Design Controls

5 years ago
RE: Customer Needs and Design Input

The design input document and design specification document each play an important role in design controls as they are the documents that proclaim official descriptions of the design. After gathering ...

In forum Introduction to Design Controls

5 years ago
RE: Making up tests for design verification and validation

Verification and validation testing are performed to ensure that the project results align with the correct user needs and specifications. Rather than looking at it from the perspective of satisfying ...

In forum Introduction to Design Controls

5 years ago
RE: Minutes for meetings

Meetings can often cover a lot of material and if meeting minutes are not recorded then there is a decent chance that some of the topics will not be acted on after the meeting. I have participated in ...

In forum Introduction to Design Controls

5 years ago
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