For Manufacturers

For Manufacturers2020-04-13T21:41:15+00:00
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Literature Review Specialists

The CiteMed Literature Report offering can fit perfectly into your projects, saving time within your firm while increasing margins.
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 The latest MDR (Reg 2017/745)  from the European commission now requires an extensive research/review component. 

If your firm has begun new CE marking procedures under this regulation, or are renewing products already at market, then you already are aware of just how time consuming and labor intensive the research based sections can be.   A quick look at a breakdown  of the components of a CE Marking Submission by time, and it becomes quite apparent that the largest (and most expensive) time consumer is the Literature Review Section.

The Importance of the Literature Review

The principal objective of the Literature Review is a ‘risk based audit’  of your product based on existing scientific literature. A well compiled Review will contain all current and relevant research, classify it properly and provide a written analysis/recommendation on the product’s current or anticipated safety results in the marketplace. 

The manual review and tabulation of relevant Articles/Studies across multiple datasources is labor intensive and often monotonous.  This costs your company:

  • Internal hours of employee productivity
  • Massively Increased Billings from External Writers
  • Delayed Time to Notified Body Submission

Hiring Staff Writers

Even with an in-house staff or regulatory professionals and writers it may still be impossible to meet the looming compliance deadlines (May 2020) for all of your products.   Taking into account the costs of complying with these additional regulatory burdens, some firms may determine that it no longer makes economical sense for some products to be marked and sold in the Eurozone all together.

Third Party Writers

Due to these concerns, many manufacturers are left no option other than to leverage third party writers to prepare their full submission paperwork.  This can be a great solution, however with external service providers costs are often undefined and project lengths left ambiguous.  For firms with limited budget and timelines, a more concise and economical solution is required.

Our Team’s Experience

CiteMed is a Regulatory Focused Company with a culture of innovation.  Our staff of seasoned regulatory writers work with our technical team to deliver the absolute best in MDR compliant Literature Reviews and product risk assessments.  

Our proprietary system uses technology to deliver a research driven risk assessment resulting in an impressive error free deliverable to clients at a fixed cost and firm deadline.

Our Literature Review

Please provide your email and we will send you  our documentation on MDR Literature Reviews

Do you offer CE Marking Services?2019-07-17T21:56:11+00:00

At this time, we are focused on delivering Literature Searches and CERs exclusively.  While we do have experienced Regulatory writers on staff that can advise you or your clients, it’s not among our service offerings.

Do you offer post market surveillance on completed products?2019-07-17T21:55:35+00:00

Yes! Contact Us today if you’d like more information on our RegHawk service.

Who are your writers? Are they qualified?2019-07-17T21:55:02+00:00

Our writers have been working in the industry for years and already have successful Notified Body submissions under their belts.  Contact Us if you’d like more information on the team.

What is your pricing?2019-08-05T16:17:18+00:00

We offer predictable pricing that’s based on the agreed upon search definition.  Both hourly and fixed rate pricing are available.  Contact Us today to see a sample report and get a full price quote for your reports.

What’s the fastest timeline you can deliver a Literature Search?2019-07-17T21:53:59+00:00

For an average project size (based on number of articles reviewed) we can turn around a fully completed and formatted Literature Search within 10 business days.  For more urgent timelines, it is possible to expedite the timeline even further.

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