What is the webinar about?
This webinar will cover BSI’s position regarding Magnetic Resonance (MR) Safety of Non-active Orthopaedic Implants. Magnetic resonance imaging (MRI) poses risks—displacement, torque, heating, and image artifacts—for orthopaedic implants, so MR safety evaluation and clear labelling in product documentation are essential. This webinar focuses on non-active orthopaedic implants by outlining EU MDR and UKCA regulatory requirements, MR safety testing methods, applicable standards, MR safety labelling, recent state-of-the-art developments, and frequent questions in conformity assessments.
Who should attend?
Manufacturers of non-active implantable medical devices especially Orthopaedic devices.
What will participants gain?
Participants will gain a clear understanding of MRI safety hazards on non-active Orthopaedic Implants (displacement force, torque, heating, and artifacts) and the EU MDR and UK requirements related to MR safety evaluation and labelling. They will also learn to apply relevant ASTM/ISO standards, and a risk-based approach to MR safety evaluation and labelling, recent state-of-the-art developments, and common issues found in conformity assessments of MR safety for orthopaedic implants.
Speakers
Kaifeng (Kai)
Liu
Sr. Technical Specialist, Orthopaedic and Dental, BSI
Dr. Kai Liu is a Medical Device Technical and Clinical Evaluation Specialist for Orthopaedic and Dental devices at BSI. He brings over eight years of experience in MDD/MDR CE marking and UKCA assessments for Class IIb and III implants, serving as BSI’s MR safety Subject Matter Expert and representing the organization on the ASTM F04.15.11 MR Safety Subcommittee. Before joining BSI, he spent more than a decade in orthopaedic R&D at Zimmer and Zimmer Biomet. He holds a Ph.D. in Mechanical Engineering from the University of Notre Dame.
Timothy
Marriot
Technical Team Manager - Orthopaedic & Dental, Regulatory Services, BSI
Dr Tim Marriott is a Technical Team Manger within the Orthopaedic and Dental team at BSI. Has worked at BSI for 8 years with responsibilities within the team for UKCA and experience as Technical Specialist, Scheme Manager and Clinical Evaluation Specialist.
Prior to this he spent 8 years working as a Principal Research Engineer at Zimmer Biomet. Bachelor degree and Doctorate from the University of Nottingham in Biomaterials.
Prior to this he spent 8 years working as a Principal Research Engineer at Zimmer Biomet. Bachelor degree and Doctorate from the University of Nottingham in Biomaterials.
Email: us.medicaldevices@bsigroup.com
Phone: +1 888 429 6178
No Results Found
'
},
pending: function () {
return 'Getting matches...
';
}
}
});
typeaheadElement.on('typeahead:select', (event, selected) => {
dunsField = Array.from(document.querySelector('.DUNS_Number').childNodes).find(node => node.tagName === 'INPUT');
dunsField.value = selected.organization.duns;
console.log(dunsField.value);
});
const countryCodes = {
"Afghanistan": "AF",
"Albania": "AL",
"Algeria": "DZ",
"American Samoa": "AS",
"Andorra": "AD",
"Angola": "AO",
"Anguilla": "AI",
"Antarctica": "AQ",
"Antigua and Barbuda": "AG",
"Argentina": "AR",
"Armenia": "AM",
"Aruba": "AW",
"Australia": "AU",
"Austria": "AT",
"Azerbaijan": "AZ",
"Bahamas": "BS",
"Bahrain": "BH",
"Bangladesh": "BD",
"Barbados": "BB",
"Belarus": "BY",
"Belgium": "BE",
"Belize": "BZ",
"Benin": "BJ",
"Bermuda": "BM",
"Bhutan": "BT",
"Bolivia": "BO",
"Bosnia and Herzegovina": "BA",
"Botswana": "BW",
"Brazil": "BR",
"British Indian Ocean Territory": "IO",
"British Virgin Islands": "VG",
"Brunei": "BN",
"Bulgaria": "BG",
"Burkina Faso": "BF",
"Burundi": "BI",
"Cambodia": "KH",
"Canada": "CA",
"Cameroon": "CM",
"Cape Verde": "CV",
"Cayman Islands": "KY",
"Central African Republic": "CF",
"Chad": "TD",
"Chile": "CL",
"China": "CN",
"Christmas Island": "CX",
"Cocos (Keeling) Islands": "CC",
"Colombia": "CO",
"Comoros": "KM",
"Congo (Kinshasa)": "CG",
"Democratic Republic of the Congo": "CD",
"Cook Islands": "CK",
"Costa Rica": "CR",
"Croatia": "HR",
"Cuba": "CU",
"Curaçao": "CW",
"Cyprus": "CY",
"Czech Republic": "CZ",
"Côte d’Ivoire": "CI",
"Denmark": "DK",
"Djibouti": "DJ",
"Dominica": "DM",
"Dominican Republic": "DO",
"Ecuador": "EC",
"Egypt": "EG",
"El Salvador": "SV",
"Equatorial Guinea": "GQ",
"Eritrea": "ER",
"Estonia": "EE",
"Ethiopia": "ET",
"Falkland Islands": "FK",
"Faroe Islands": "FO",
"Fiji": "FJ",
"Finland": "FI",
"France": "FR",
"French Guiana": "GF",
"French Polynesia": "PF",
"French Southern Territories": "TF",
"Gabon": "GA",
"Gambia": "GM",
"Georgia": "GE",
"Germany": "DE",
"Ghana": "GH",
"Gibraltar": "GI",
"Greece": "GR",
"Greenland": "GL",
"Grenada": "GD",
"Guadeloupe": "GP",
"Guam": "GU",
"Guatemala": "GT",
"Guernsey": "GG",
"Guinea": "GN",
"Guinea-Bissau": "GW",
"Guyana": "GY",
"Haiti": "HT",
"Honduras": "HN",
"Hong Kong": "HK",
"Hungary": "HU",
"Iceland": "IS",
"India": "IN",
"Indonesia": "ID",
"Iran": "IR",
"Iraq": "IQ",
"Ireland": "IE",
"Isle of Man": "IM",
"Israel": "IL",
"Italy": "IT",
"Jamaica": "JM",
"Japan": "JP",
"Jersey": "JE",
"Jordan": "JO",
"Kazakhstan": "KZ",
"Kenya": "KE",
"Kiribati": "KI",
"Kuwait": "KW",
"Kyrgyzstan": "KG",
"Korea": "KR",
"Laos": "LA",
"Latvia": "LV",
"Lebanon": "LB",
"Lesotho": "LS",
"Liberia": "LR",
"Libya": "LY",
"Liechtenstein": "LI",
"Lithuania": "LT",
"Luxembourg": "LU",
"Macao S.A.R.": "MO",
"Macedonia": "MK",
"Madagascar": "MG",
"Malawi": "MW",
"Malaysia": "MY",
"Maldives": "MV",
"Mali": "ML",
"Malta": "MT",
"Marshall Islands": "MH",
"Martinique": "MQ",
"Mauritania": "MR",
"Mauritius": "MU",
"Mayotte": "YT",
"Mexico": "MX",
"Micronesia": "FM",
"Moldova": "MD",
"Monaco": "MC",
"Mongolia": "MN",
"Montenegro": "ME",
"Montserrat": "MS",
"Morocco": "MA",
"Mozambique": "MZ",
"Myanmar": "MM",
"Namibia": "NA",
"Nauru": "NR",
"Nepal": "NP",
"Netherlands": "NL",
"New Caledonia": "NC",
"New Zealand": "NZ",
"Nicaragua": "NI",
"Niger": "NE",
"Nigeria": "NG",
"Niue": "NU",
"Norfolk Island": "NF",
"Northern Mariana Islands": "MP",
"Norway": "NO",
"Oman": "OM",
"Pakistan": "PK",
"Palau": "PW",
"Palestinian Territory": "PS",
"Panama": "PA",
"Papua New Guinea": "PG",
"Paraguay": "PY",
"Peru": "PE",
"Philippines": "PH",
"Pitcairn": "PN",
"Poland": "PL",
"Portugal": "PT",
"Puerto Rico": "PR",
"Qatar": "QA",
"Romania": "RO",
"Russia": "RU",
"Rwanda": "RW",
"Réunion": "RE",
"Saint Barthélemy": "BL",
"Saint Helena": "SH",
"Saint Kitts and Nevis": "KN",
"Saint Lucia": "LC",
"Saint Pierre and Miquelon": "PM",
"Saint Vincent and the Grenadines": "VC",
"Samoa": "WS",
"San Marino": "SM",
"Sao Tome and Principe": "ST",
"Saudi Arabia": "SA",
"Senegal": "SN",
"Serbia": "RS",
"Seychelles": "SC",
"Sierra Leone": "SL",
"Singapore": "SG",
"Slovakia": "SK",
"Slovenia": "SI",
"Solomon Islands": "SB",
"Somalia": "SO",
"South Africa": "ZA",
"South Sudan": "SS",
"Spain": "ES",
"Sri Lanka": "LK",
"Sudan": "SD",
"Suriname": "SR",
"Svalbard and Jan Mayen": "SJ",
"Swaziland": "SZ",
"Sweden": "SE",
"Switzerland": "CH",
"Syria": "SY",
"Taiwan": "TW",
"Tajikistan": "TJ",
"Tanzania": "TZ",
"Thailand": "TH",
"Timor-Leste": "TL",
"Togo": "TG",
"Tokelau": "TK",
"Tonga": "TO",
"Trinidad and Tobago": "TT",
"Tunisia": "TN",
"Turkey": "TR",
"Turkmenistan": "TM",
"Turks and Caicos Islands": "TC",
"Tuvalu": "TV",
"U.S. Virgin Islands": "VI",
"Uganda": "UG",
"Ukraine": "UA",
"United Arab Emirates": "AE",
"United Kingdom": "GB",
"United States of America": "US",
"United States Minor Outlying Islands": "UM",
"Uruguay": "UY",
"Uzbekistan": "UZ",
"Vanuatu": "VU",
"Vatican": "VA",
"Venezuela": "VE",
"Viet Nam": "VN",
"Wallis and Futuna": "WF",
"Western Sahara": "EH",
"Yemen": "YE",
"Zambia": "ZM",
"Zimbabwe": "ZW"
}
