-
1
-
-
79956314558
-
Eucomed Q&A: Where do EU regs get it right? An emphasis on innovation
-
Bylander J. Eucomed Q&A: where do EU regs get it right? An emphasis on innovation. The Gray Sheet 2011;37(Mar 14):1.
-
(2011)
The Gray Sheet
, vol.37
, Issue.MAR 14
, pp. 1
-
-
Bylander, J.1
-
2
-
-
84857853896
-
-
PricewaterhouseCoopers. Medical technology innovation scorecard. 2011. http://pwchealth.com/cgi-local/hregister.cgi?link=reg/innovation-scorecard.pdf.
-
(2011)
Medical Technology Innovation Scorecard
-
-
-
3
-
-
84859007846
-
EU regulatory system brings Europeans fastest access to medical technology without compromising safety
-
28 Jan
-
Wilkinson J. EU regulatory system brings Europeans fastest access to medical technology without compromising safety. Eucomed press release, 28 Jan 2011. www.eucomed.org/newsroom/8/19/EU-regulatory-system-brings-Europeans- fastest-access-to-medical-technology-without-compromising-safety/.
-
(2011)
Eucomed Press Release
-
-
Wilkinson, J.1
-
4
-
-
85057955922
-
Guinea pig remark spurs US, EU device spat
-
Feb 24
-
Richwine L. "Guinea pig" remark spurs US, EU device spat. Reuters 2011 Feb 24. www.reuters.com/article/2011/02/25/us-devices- idUSTRE71O0P020110225.
-
(2011)
Reuters
-
-
Richwine, L.1
-
7
-
-
78349257102
-
How medical devices are regulated in the UK
-
How medical devices are regulated in the UK. Drugs Ther Bull 2010;48:82-4.
-
(2010)
Drugs Ther Bull
, vol.48
, pp. 82-84
-
-
-
8
-
-
79956297293
-
Clinical evaluation of cardiovascular devices - Principles, problems and proposals for European regulatory reform
-
Fraser AG, Daubert JC, van de Werf F, Estes NA, Smith SC Jr. Clinical evaluation of cardiovascular devices - principles, problems and proposals for European regulatory reform. Eur Heart J 2011 http://eurheartj.oxfordjournals. org/cgi/reprint/ehr171.
-
(2011)
Eur Heart J
-
-
Fraser, A.G.1
Daubert, J.C.2
Van De Werf, F.3
Estes, N.A.4
Smith Jr., S.C.5
-
10
-
-
84859002868
-
-
European Commission Enterprise and Industry
-
European Commission Enterprise and Industry. Notified bodies. http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive. notifiedbody&dir-id=13&type-dir=NO%20CPD&pro-id=99999&prc-id= 99999&ann-id=99999&prc-anx=99999.
-
Notified Bodies
-
-
-
11
-
-
84859005284
-
-
European Commission Enterprise and Industry Directorate General Rev 3. December
-
European Commission Enterprise and Industry Directorate General. Clinical evaluation: a guide for manufacturers and notified bodies MEDDEV 2.7.1 Rev 3. December 2009. http://ec.europa.eu/consumers/sectors/medical-devices/files/ meddev/2-7-1rev-3-en.pdf
-
(2009)
Clinical Evaluation: A Guide for Manufacturers and Notified Bodies MEDDEV 2.7.1
-
-
-
12
-
-
44049090675
-
Registers needed for new interventional procedures
-
DOI 10.1016/S0140-6736(08)60742-4, PII S0140673608607424
-
Lyratzopoulos G, Patrick H, Campbell B. Registers needed for new interventional procedures. Lancet 2008;371:1734-6. (Pubitemid 351711659)
-
(2008)
The Lancet
, vol.371
, Issue.9626
, pp. 1734-1736
-
-
Lyratzopoulos, G.1
Patrick, H.2
Campbell, B.3
-
14
-
-
84857863524
-
Medical device recalls in the UK and the device regulation process: Retrospective review of safety notices and alerts
-
doi:10.1136/bmjopen-2011-0155
-
Heneghan C, Thompson M, Billingsley M, Cohen D. Medical device recalls in the UK and the device regulation process: retrospective review of safety notices and alerts. BMJ Open doi:10.1136/bmjopen-2011-0155.
-
BMJ Open
-
-
Heneghan, C.1
Thompson, M.2
Billingsley, M.3
Cohen, D.4
-
15
-
-
84859006229
-
Debate on 510(k)s and recalls reaches Capitol Hill
-
Feb 18
-
Shuren J. Debate on 510(k)s and recalls reaches Capitol Hill. theheart.org 2011 Feb 18. www.theheart.org/article/1188437.do
-
(2011)
Theheart.org
-
-
Shuren, J.1
-
17
-
-
84858998112
-
-
House Committee on Energy and Commerce, February 17
-
Redberg RF. Testimony to subcommittee on health, House Committee on Energy and Commerce, February 17, 2011. http://republicans.energycommerce.house. gov/Media/file/Hearings/Health/021711-Health/RitaRedberg.pdf.
-
(2011)
Testimony to Subcommittee on Health
-
-
Redberg, R.F.1
-
18
-
-
84870992917
-
-
US Food and Drug Administration. Medical devices: premarket approval. www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ premarketsubmissions/premarketapprovalpma/default.htm.
-
Medical Devices: Premarket Approval
-
-
-
19
-
-
84881424178
-
-
US Food and Drug Administration. Medical devices: premarket notification (510k). www.fda.gov/medicaldevices/deviceregulationandguidance/ howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default. htm.
-
Medical Devices: Premarket Notification (510k)
-
-
-
20
-
-
79956334051
-
-
Press release, 1 April
-
Agence Francaise de Securite Sanitaire des Produits de Sante. Silicone filled breast implants manufactured by Poly Implant Prosthese (PIP). Press release, 1 April 2010. www.afssaps.fr/var/afssaps-site/storage/original/ application/ff8f7014c6ee1b6674c8fb7dd2835840.pdf.
-
(2010)
Silicone Filled Breast Implants Manufactured by Poly Implant Prosthese (PIP)
-
-
-
23
-
-
79955726540
-
Medical device recalls and the FDA approval process
-
Feb 14 [Epub ahead of press]
-
Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med 2011; Feb 14 [Epub ahead of press].
-
(2011)
Arch Intern Med
-
-
Zuckerman, D.M.1
Brown, P.2
Nissen, S.E.3
-
26
-
-
84859006163
-
EU seriously failing post-market surveillance, says UK regulator
-
May 19
-
Maxwell A. EU seriously failing post-market surveillance, says UK regulator. Clinica 2010 May 19. www.clinica.co.uk/policyregulation/vigilance/EU- seriously-failing-post-market-surveillance-says-UK-regulator-289356?autnID=/ contentstore/clinica/codex/c7189da9-6257-11df-bc1e-c5d67941f290.xml.
-
(2010)
Clinica
-
-
Maxwell, A.1
-
27
-
-
33646744337
-
Under-reporting of adverse drug reactions: A systematic review
-
Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Safety 2006;29:385-96.
-
(2006)
Drug Safety
, vol.29
, pp. 385-396
-
-
Hazell, L.1
Shakir, S.A.W.2
-
28
-
-
84859002863
-
Windeler of change: Medtech must prove its worth, insists German HTA chief
-
Jan 6
-
Yeo A. Windeler of change: medtech must prove its worth, insists German HTA chief Clinica 2011 Jan 6. www.clinica.co.uk/policyregulation/Windeler-of- change-medtech-must-prove-its-worth-insists-German-HTA-chief-308183?autnID=/ contentstore/clinica/codex/f964fd9f-083c-11e0-bd26-b56fabe1b06f.xml.
-
(2011)
Clinica
-
-
Yeo, A.1
|