Forum

maniakberk
@maniakberk
Eminent Member
Joined: Sep 5, 2020
Last seen: Nov 29, 2020
Topics: 2 / Replies: 44
Reply
RE: Restrictions for physician's gifts

Sunshine laws are regulations created to deal with these kinds of conflicts. In most basic, it requires business in multiple different industries and ...

4 years ago
Reply
RE: Severance and Release Agreement

Personally, I have never been offered such an agreement, but I do know of them. In most basic terms, these agreements are to fire employees without an...

4 years ago
Reply
RE: Advice before signing an NDA

The best advice would be to READ AND UNDERSTAND the document FULLY. Furthermore, the language must be precise and to the point so that no secondary me...

4 years ago
Reply
RE: NDA vs Patents

NDA or Non-Disclosure Agreement is simply a contract. If that contract is violated in any way, there is a chance to sue the one who violated the contr...

4 years ago
Reply
RE: Non Compete Agreement

A NON-Compete Agreement is a contract made between the employer and its employees. It means that the employee agrees not to enter in any direct compet...

4 years ago
Reply
RE: Written Agreement v/s Verbal Agreement

Verbal agreements mean that the topic at hand is agreed upon by spoken communication. Personally, I do not believe the can be such a thing as a "PROFE...

4 years ago
Reply
RE: Consultants in the Medical Device Industry

There are a lot of consultants in the medical device industry. N most basic, they all have a deep understanding of ISO9001 and ISO 13485. Not every me...

4 years ago
Reply
RE: Risk management methods

I like to talk about Basic risk management methods. As jp582 mentioned, it is basically making a checklist of factors for the related project. This ch...

4 years ago
Reply
RE: Dealing with risk

Dealing with risk, there are certain steps to follow. To start with, a risk register must be created. A risk register is basically a spreadsheet that ...

4 years ago
Reply
RE: Factors Contributing to Risk Values

I want to talk about Magnetic Resonance Imaging (MRI) or Functional MRI (fMRI) in risk management. Although both MRI and fMRI were really useful both ...

4 years ago
Reply
RE: Important Part of DDP

To start with, DDP stands for design and development plans. DDP aims to describe the product or design to create a chart of its production cycle, mark...

4 years ago
Reply
RE: Minutes for meetings

I personally had a checklist for my meetings. In the checklist, I mainly controlled for some major topics. This checklist is, of course, gets to be cu...

4 years ago
Reply
RE: Statistical Sampling

When working as a Biomedical Engineering Technician for an international company, one of my customers was using the Elisa device irresponsibly. Meanin...

4 years ago
Reply
RE: What FDA Looks For In A Design Control System ?

There are various things that the FDA will be looking for in a Design Contol System. (1)Design and development planning. (2)Design input: It has infor...

4 years ago
Reply
RE: Design Controls in the other countries

The design control process in Turkey is done by the Turkish Medicines and Medical Devices Agency. It follows ISO 13485 and ISO 9001. For Turkey, medic...

4 years ago
Page 1 / 4