Most medical device companies are finding that they need to revise their Clinical Evaluation Reports (CERs) in order to be compliant with the new EU MDR requirements. This may also require revision of internal standard operating procedures. Mileva Med offers the most affordable professional medical writing services available to medical device manufacturers.
Let us help you with:
- Clinical Evaluation Reports (CERs)
- Clinical Study Reports (CSRs)
- Protocols/ Clinical Investigational Plans (CIP)
- Standard Operating Procedures (SOPs), Forms, Work Instructions, and other Controlled Documents
- Investigator’s Brochures (IB)
- Informed Consent Documents (ICF)
- Scientific Publications, Abstracts, Posters, Manuscripts, and Podium Presentations
- Regulatory Applications and Submissions
Raiszadeh R, Raiszadeh K, Eaton L, Kim P, and Kim C. Effectiveness of combined magnetic therapy (CMF) bone growth stimulation on lumbar spinal fusion outcomes: a single center retrospective analysis comparing CMF to no-stimulation or other stimulators. 2020 May ;6(3) :xxx-xxx. ePub ahead of print 9Mar2020. DOI : http://dx.doi.org/10.18203/issn.2455-4510.IntJResOrthop20201062
Ronan S, Eaton L, Lehman A, Pilcher B, and Erickson C. Histological Characterization of Polymethymethacrylate Dermal Filler Biostimulatory Properties in Human Skin. Dermatol Surg 2019 Dec;45(12): 1580-84. DOI: 10.1097/DSS.0000000000001877
Joseph J, Shamban A, Eaton L, et al. Polymethylmethacrylate (PMMA) Collagen Gel Injectable Dermal Filler for Atrophic Acne Scar Correction in the Full Facial Area. Dermatol Surg 2019;45(12):1558-1566. DOI: 10.1097/DSS0000000000001863
O’Brien JB, Eaton LL, Curry T. Health outcomes and explant rates after laparoscopic adjustable gastric banding: a phase 4, multicenter study over 5 years. Obesity (Silver Spring). 2018 Jan;26(1):45-52.
Courcoulas A, Abu Dayyeh B, Eaton LL, Woodman G, Fusco M, et al. Intragastric balloon as an adjunct to lifestyle intervention for weight reduction in lower body mass index individuals. Intl J Obesity, 2017 Mar;41(3)427-433.
Joseph J, Eaton L, Robinson J, Pontius A, and Williams EF. Does increasing the dose of abobotulinumtoxinaA impact the duration of effectiveness for the treatment of moderate to severe glabellar lines? J Drugs Dermatol, 2016 Dec;15(12)611-616.
Dixon J, Eaton LL, Vincent V, Michaelson R. LAP-BAND® for BMI 30-40: 5-year health outcomes from the multicenter pivotal study. Int J Obes (Lond). 2016 Feb;40(2):291-8.
Joseph JH, Eaton LL, and Cohen SR. Current concepts in the use of Bellafill®. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):171s-179s. Joseph JH and Eaton LL. The case for synthetic injectables. Facial Plast Surg Clin North Am. 2015 Nov;23(4):433-45.
Sundaram H, Shamban A, Schlessinger J., Kaufman-Janette J, Joseph J, Lupin M, Darelos Z, Carey W, Smith S, and Eaton L. A randomized, blinded, no-treatment control, multicenter prospective clinical study of a resilient hyaluronic acid for the treatment of moderate-to-severe perioral rhytids. IMCAS 2020
Ronan S, Eaton L, Lehman A, Pilcher B, and Erickson C. Histological Analysis of Bellafill Injected Tissue at Various Timepoints: A Proof of Concept Study. ASDS. 2018 Oct.
Dixon J, Eaton L, Coburn C, and Curry T. Health outcomes from the HERO Study: A prospective, multicenter, non-randomized study of health outcomes and rates of explants after 5 years of treatment with laparoscopic adjustable gastric banding. ASMBS/Obesity Week, 2016 Oct.
Dixon J, and Eaton LL. The explant rate of laparoscopic adjustable gastric bands: Data from two carefully monitored US studies. ASMBS/Obesity Week, 2015 Nov.