{"id":3430,"date":"2022-02-24T14:10:17","date_gmt":"2022-02-24T14:10:17","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3430"},"modified":"2022-11-04T18:14:43","modified_gmt":"2022-11-04T18:14:43","slug":"medical-device-safety","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/medical-device-safety\/","title":{"rendered":"Medical Device Safety"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_fullwidth_image src=”https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-medizinprodukte-min.jpg” alt=”Pharma & Medizinprodukte” title_text=”Medizinprodukte” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_margin=”||0px||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.18.1″ text_font=”||||||||” text_line_height=”2em” header_font=”Manrope|600|||||||” header_text_color=”#20292f” header_font_size=”26px” header_line_height=”1.3em” header_2_font=”Manrope|600||on|||||” header_2_text_color=”#193b7a” header_2_font_size=”14px” header_2_letter_spacing=”1px” header_2_line_height=”1.2em” header_3_font=”Manrope|500|||||||” header_3_font_size=”20px” header_3_line_height=”1.4em” custom_margin=”0px||0px||false|false” hover_enabled=”0″ header_2_font_size_tablet=”42px” header_2_font_size_phone=”32px” header_2_font_size_last_edited=”off|desktop” header_3_font_size_tablet=”28px” header_3_font_size_phone=”20px” header_3_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

Medical Device Safety<\/h2>\n

We take care of everything for you: from notification requirements to vigilance and post-market surveillance (PMS)<\/h1>\n

[\/et_pb_text][et_pb_text _builder_version=”4.18.1″ _module_preset=”default” text_font=”Manrope||||||||” text_text_color=”#6d7c90″ header_font=”Manrope|600|||||||” custom_margin=”0px||||false|false” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

For the US<\/strong> market<\/strong> the FDA<\/strong> Adverse Event Reporting<\/strong> is regulated in the CFR 820 Part 803<\/a><\/strong>. The risk management process ISO 14971<\/strong><\/a> is fundamental for the safety of medical devices and reducing risk. We help you with investigator’s observations (FDA 483<\/a>), changes in medical devices in the meaning of 21 CFR 807.81(a)(3) etc.\u00a0<\/strong><\/p>\n

For the European market, <\/strong>the directive 2007\/47\/EC<\/strong><\/a> of the European Parliament and of the council of 5 September 2007 amending Council Directive 90\/385\/EEC are\u00a0 relevant. It includes the requirements for market surveillance<\/strong> as well as the revision of the clinical evaluation based on data obtained from post-market surveillance of the medical device.<\/p>\n

According to the Medical Devices Safety Plan Ordinance (MPSV)<\/strong><\/a>, manufacturers, operators, users, and distributors of a medical device are obligated to report incidents (product-related adverse events) without delay to the competent higher federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) <\/strong><\/a>or the Paul Ehrlich Institute (PEI)<\/strong><\/a>, in order to prevent hazards (vigilance)<\/strong>. A reportable incident is defined as a malfunction, failure, change in characteristics or performance,or improper labeling or instructions for the use of a medical device that has led, could have led, or could lead directly or indirectly to the death or serious deterioration of the health status of a patient, user, or other person. The BfArM assesses the risk of the incident. For this purpose, the manufacturer takes corrective measures in cooperation with the BfArM to eliminate the existing risk.<\/p>\n

The European Medical Device Regulation (EU) 2017\/745\u00a0<\/strong><\/a> requires that manufacturers systematically collect information on the use of a medical device after it has been placed on the European market and monitor their products (post-market surveillance [PMS]\/vigilance). Manufacturers must update the technical documentation of their medical devices based on collected data and coordinate it with national vigilance and market surveillance authorities tp provide corrective or preventive actions (CAPA)<\/strong>. The goal of this approach is to increase the safety<\/strong> and performance of medical devices<\/strong>.<\/p>\n

Another medical device safety<\/strong> measure is post-market clinical follow-up (PMCF)<\/strong>. It involves the clinical follow-up of a medical device after it has been placed on the market. This follow-up must be continual and is part of the clinical evaluation<\/strong><\/a> in the context of post-market surveillance (MDR, Annex XIV)<\/strong>.<\/p>\n

We would be happy to support you with medical device safety challenges. Just contact us!<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”\/en\/contact” button_text=”Make a consultation appointment” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”13px” button_text_color=”#FFFFFF” button_bg_color=”#16918f” button_border_width=”4px” button_border_color=”#16918f” button_border_radius=”0px” button_font=”Manrope|||on|||||” button_icon=”$||divi||400″ button_icon_color=”#FFFFFF” background_layout=”dark” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Service Section” _builder_version=”4.16″ background_color=”#f7f7f7″ custom_margin=”0px||0px||false|false” custom_padding=”70px||70px||false|false” global_colors_info=”{}”][et_pb_row admin_label=”Service Section Title” _builder_version=”4.16″ custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” animation_style=”fade” animation_direction=”top” saved_tabs=”all” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”Title” _builder_version=”4.16″ text_font=”Montserrat||||||||” text_text_color=”#747d88″ text_line_height=”1.9em” header_font=”||||||||” header_2_font=”Manrope|600|||||||” header_2_text_color=”#20292f” header_2_line_height=”1.4em” text_orientation=”center” max_width=”700px” module_alignment=”center” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”4%” global_colors_info=”{}”]<\/p>\n

Our medical device safety \/ post-market surveillance (PMS) measures:<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” admin_label=”Services” _builder_version=”4.16″ max_width=”80%” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n

Establishment<\/strong> of a vigilance system \/ reporting <\/strong>of incidents <\/strong>at the BfArM<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n

Post-market clinical<\/strong>
follow-up, other studies<\/strong><\/p>\n

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Literature monitoring<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

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Continuous review <\/strong>and update <\/strong>of clinical evaluation<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

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Market analyses<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

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Batch testing\/ random sample testing<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n

Production monitoring<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n

Observation of competitors<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

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Evaluation <\/strong>and action measures<\/strong>
(possibly off-label use)<\/strong><\/p>\n

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Quality management<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n

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Medical Device Safety We take care of everything for you: from notification requirements to vigilance and post-market surveillance (PMS)For the US market the FDA Adverse Event Reporting is regulated in the CFR 820 Part 803. The risk management process ISO 14971 is fundamental for the safety of medical devices and reducing risk. We help you […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"

[et_pb_section fb_built=\"1\" fullwidth=\"on\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_fullwidth_image src=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-medizinprodukte-min.jpg\" alt=\"Pharma & Medizinprodukte\" title_text=\"Medizinprodukte\" _builder_version=\"4.11.4\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=\"1\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_row _builder_version=\"4.10.7\" custom_margin=\"||0px||false|false\" custom_padding=\"0px||0px||false|false\" locked=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_text _builder_version=\"4.14.2\" text_font=\"||||||||\" text_line_height=\"2em\" header_font=\"Manrope|600|||||||\" header_text_color=\"#20292f\" header_font_size=\"26px\" header_line_height=\"1.3em\" header_2_font=\"Manrope|600||on|||||\" header_2_text_color=\"#193b7a\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.2em\" header_3_font=\"Manrope|500|||||||\" header_3_font_size=\"20px\" header_3_line_height=\"1.4em\" custom_margin=\"0px||0px||false|false\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"]<\/p>

Medizinprodukte-Sicherheit<\/h2>

Wir \u00fcbernehmen alles f\u00fcr Sie: von den Meldepflichten \u00fcber die Vigilanz bis hin zur Post-Market Surveillance (PMS)<\/h1>

[\/et_pb_text][et_pb_text _builder_version=\"4.14.2\" _module_preset=\"default\" text_font=\"Manrope||||||||\" text_text_color=\"#6d7c90\" header_font=\"Manrope|600|||||||\" custom_margin=\"0px||||false|false\" global_colors_info=\"{}\"]<\/p>

Die \u00c4nderungsrichtlinie 2007\/47\/EG<\/strong> beinhaltet die Anforderungen f\u00fcr die Markt\u00fcberwachung<\/strong> sowie die Revisionierung der klinischen Bewertung auf Basis der erhaltenen Daten aus der \u00dcberwachung nach dem Inverkehrbringen des Medizinproduktes.<\/p>

Die Hersteller, Betreiber, Anwender und H\u00e4ndler eines Medizinprodukts sind gem\u00e4\u00df der Medizinprodukte\u2010Sicherheitsplanverordnung (MPSV) <\/strong><\/a>verpflichtet, Vorkommnisse<\/strong> (produktbezogene unerw\u00fcnschte Ereignisse)\u00a0unverz\u00fcglich der zust\u00e4ndigen Bundesoberbeh\u00f6rde<\/strong>, dem Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (BfArM)<\/a>,<\/strong> bzw. an das Paul Ehrlich\u2010Institut (PEI)<\/strong> <\/a>zu melden<\/strong>, um vorbeugend Gefahren abzuwehren (Vigilanz)<\/strong>.\u00a0Ein meldepflichtiges Vorkommnis ist definiert als eine Funktionsst\u00f6rung, ein Ausfall, eine \u00c4nderung der Merkmale oder der Leistung, eine unsachgem\u00e4\u00dfe Kennzeichnung oder Gebrauchsanweisung eines Medizinprodukts, die unmittelbar oder mittelbar zum Tod oder zu einer schwerwiegenden Verschlechterung des Gesundheitszustandes eines Patienten, eines Anwenders oder einer anderen Person gef\u00fchrt hat, gef\u00fchrt haben k\u00f6nnte oder f\u00fchren k\u00f6nnte. Das BfArM bewertet das Risiko des Vorkommnisses. Hierzu ergreift der Hersteller in Zusammenarbeit mit dem BfArM korrektive Ma\u00dfnahmen zur Beseitigung des bestehenden Risikos.<\/p>

Die europ\u00e4ische Medizinprodukte-Verordnung (EU) 2017\/745 \/ Medical Device Regulation (MDR)<\/strong> <\/a>verlangt, dass Hersteller nach dem Inverkehrbringen eines Medizinproduktes im europ\u00e4ischen Markt Informationen zur Produktverwendung systematisch zusammentragen und ihre Produkte \u00fcberwachen (Post-Market Surveillance (PMS) \/ Vigilanz)<\/strong>. Die Hersteller m\u00fcssen auf Basis dieser gesammelten Daten die technische Dokumentation ihrer Medizinprodukte aktualisieren und diese mit den nationalen Beh\u00f6rden f\u00fcr Vigilanz- und Markt\u00fcberwachung abstimmen (Korrektur- oder Pr\u00e4ventivma\u00dfnahmen<\/strong>). Ziel dieser Vorgehensweise ist, die Sicherheit und Leistungsf\u00e4higkeit von Medizinprodukten zu erh\u00f6hen<\/strong>.<\/p>

Eine weitere Ma\u00dfnahme der Medizinprodu<\/strong>kte-Sicherheit <\/strong>ist das Post-Market Clinical Follow-Up (PMCF).<\/strong> Es umfasst die klinische Nachbeobachtung eines Medizinproduktes nach dem Inverkehrbringen. Diese Nachbeobachtung muss kontinuierlich erfolgen und ist Teil der klinischen Bewertung<\/strong><\/a> im Rahmen der Post-Market Surveillance<\/strong> (MDR, Anhang XIV<\/strong>).<\/p>

Gerne unterst\u00fctzen wir Sie bei Herausforderungen der Medizinprodukte-Sicherheit. Sprechen Sie uns einfach an!<\/strong><\/p>

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Unsere Ma\u00dfnahmen zur Medizinproduktesicherheit \/ Post-Market Surveillance (PMS):<\/h2>

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Einrichtung<\/strong> eines Vigilanz-Systems\u00a0<\/strong>\/ Meldung<\/strong>\u00a0von\u00a0Vorkommnissen<\/strong>\u00a0
beim\u00a0BfArM<\/strong><\/p>

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Post-Market\u00a0Clinical
Follow\u2010up<\/strong>,\u00a0sonstige\u00a0Studien<\/p>

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Literaturbeobachtung<\/strong><\/p>

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Kontinuierliche \u00dcberpr\u00fcfung<\/strong> und Aktualisierung<\/strong> der klinischen Bewertung<\/strong><\/p>

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Marktanalysen<\/strong><\/p>

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Chargenpr\u00fcfungen<\/strong>\/ Stichprobenpr\u00fcfungen<\/strong><\/p>

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Produktions\u00fcberwachung<\/strong><\/p>

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Beobachtung\u00a0<\/strong>von\u00a0Mitbewerbern<\/strong><\/p>

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Bewertung<\/strong>\u00a0und\u00a0Ma\u00dfnahmen<\/strong>
(evtl. Off\u2010Label Use)<\/strong><\/p>

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Qualit\u00e4tsmanagement\u200b<\/strong><\/p>

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