Emergo Group established in 1997, assists medical device companies with a global regulatory strategy, device registration, quality management system compliance, clinical trial consulting, in-country regulatory representation, training, etc.Skills:- US and European Regulatory strategies- Clinical Evaluation Plans and Reports (MEDDEV 2.7/1 rev.4 and MDR)- Risk Management Files (EN ISO 14971:2012)- Technical Files (STED format - MDD/MDR)- 510(k)s, 513(g)s- Regulatory and Quality Support- Quality System implementation- Internal/Mock Audit (QSR, ISO 13485, RDC16/2013, MDR)- MDSAP audit (with 5 countries)- Audit support (CE; ISO 13485)- FDA inspections and FDA-483 responses- Trainer (EN ISO 14971/2012; 510(k) preparation, QSR, ISO 13485, audit, vigilance, clinical evaluation)- French Registrations of medical devicesWhite Papers: - Unannounced audit in Europe under 2013-473/EU(https://www.emergobyul.com/resources/articles/white-paper-unannounced-audits-and-critical-suppliers-europe)- ISO11135:2014 EO sterilization (https://www.emergobyul.com/resources/articles/white-paper-iso-11135-new-sterilization-requirements)- ISO10993-1:2009 biocompatibility (https://www.emergobyul.com/resources/articles/white-paper-iso-10993-biocompatibility)- ISO13485:2016 a risk based approach (https://www.emergobyul.com/resources/iso-134852016-and-new-risk-based-approach)- PMS&PSUR under MDR (https://www.emergobyul.com/resources/pms-psur-requirements-under-eu-mdr)

Covidien develops surgical mesh indicated for hernia repair.- Definition of regulatory strategies to obtain clearances for European (class III), American (class II) andinternational markets.- Creation and submission of regulatory documentation (EU: annex II.4, USA: 510(k)).- Management of technical documentation.- Support for international registrations (Japan, China,…).- Registrations renewal.- In charge of the regulatory tasks in the Change Control process- Reviewer or Approver of Design History File documentation (DHF).- Involvement in design verification/validation and preclinical testing.Quality System Improvement: Change Control Process

Integra develops orthopaedic implant and prosthesis for foot and ankle.- Definition of regulatory strategies to obtain clearances for European (class IIb), American (class II).- Creation of submission file (510(k)).- Support for international registrations (China, Canada,…).- Management of technical documentation (EU: annex II.3).- In charge of regulatory tasks in the Change Control process.- Accountable for the risk management process.- Involvement in the design verification/validation.- Complaints, recalls and field safety notices management – Regular contact with competent authorities and notified bodies.- Post Market Surveillance activities.- Involvement in the management of CAPA, non-compliances and derogations.- Approver of marketing documentation (poster, surgical technique, video, catalog,...).Quality System Improvements: risk management & packaging validation procedures.

Alcis is specialized in the development of new technologies (Design / Manufacturing / Quality / Regulary) for its clients. Alcis mainly develops surgical implant for neurosurgery in the epilepsy treatment.- Definition of regulatory strategies to obtain clearances in Europe.- Definition and submission of the regulatory documentation (EU: annex II.3).- Management of the technical documentation.- Packaging validation.- Accountable for the risk management process.- Involvement in the design verification/validation.- Project management activities: planning, customer contact (surgeon, sales rep), specification file, quality agreement, subcontractor management, testing implementation in clean room.Quality System Improvement: Risk analysis procedure