SK

I would be careful of a significant price hike from them.

Strengths: They have a lot of experience in the medical device industry.

Needs to improve: They increased the price for the contract manufactured catheter by 40%. This was too much of an increase. They also do not attract the highest quality engineers to this company.

Bad experience. My company is never going to use them again.

Strengths: Reading the bios of the consultants on the website, they do have many people with relevant experience and the right backgrounds.

Needs to improve: My company used Myraqa for medical device consulting services for a specific project and we were disappointed in what they provided and shocked with how many hours they billed us for. We asked for very specific items, and instead of delivering and answering our specific requests, they provided us with other information and billed us for the time that they spent in giving us non-helpful information. In addition, instead of having just one or two people involved, they used three separate people (i.e., two regulatory and one statistician) and it felt as though our bill tripled with the total number of hours they charged. In addition, the statistician had very poor communication skills (both in writing and in speaking).

This was the worst experience I've had with software for EDMS and quality systems - poorly designed products and poor service. I would never recommend their software to anyone.

Strengths: Out of several quotes for electronic document management systems, their quote was not the most expensive one.

Needs to improve: They overpromise and underdeliver. The salesperson will make statements that are false. The actual software is poorly designed, with lots of defects and low usability. I've been at 5 medical device companies with various electronic document management systems and software for quality management systems, and Pilgrim had the worst software compared to the others.

We have used Emergo to assist in medical device registration and approval in Australia, and to provide information on regulatory pathways in various countries for our unique medical device technology. The consultants that worked with us were a pleasure to interact with and provided useful information.

Strengths: They offer medical device consulting expertise in various International markets, and have in-country representatives (which is often required) in many OUS countries. They have knowledgeable and experienced consultants for the medical device industry.

Needs to improve: none encountered

They are very quick to provide you with a quote for the estimated turnaround time and cost. They provide high-quality translations which is required for the medical device industry. Top-notch services and they will not provide you with a low-quality translation.

Strengths: 1. ISO 13485:2003 certified quality process for translations and you will receive a certificate of accuracy.
2. rigorous screening process ensures that the linguists are top-notch and have the right expertise.
3. over 30 years of experience for translations in the life science industry.
4. professional, reliable, services and good turnaround times for translations.

Needs to improve: none encountered.