Advice Pharma is a ‘biodigital’ full service CRO, supporting pharmaceutical and biomedical companies in clinical trial management, digital therapeutics development and digital research transformation. Advice Pharma is specialized in Real World Evidence studies worldwide, manages observational, interventional, and decentralized clinical trials on MD and drugs, and have experience as legal manufacturers (SaMD; certified ISO 13485).
Be-on-Quality GmbH is a full-scope medical device regulatory solution provider, which can deliver the full area of service and provides support for all regulatory and quality management issues to bring MDs or IVDs to the market, including ISO13485, 2017/745 MDR , 2017/746 IVDR, US FDA, software as medical device, electrical safety, EMC, clinical evaluation…
Chino offers a unique combination of legal and technical expertise, with a modular IT platform, to help digital health and med tech companies to solve privacy regulatory challenges and to ensure compliance with regulations such as GDPR, HIPAA (US), HDS (FR), DVG (DE), DTAC (UK), or to pass Vendor Risk Assessments with customers and partners.
Effectum Medical, specializes in providing regulatory affairs and quality management services to the medical devices industry. Our offerings include two distinct QMS solutions: - A user-friendly plug & play (e)QMS solution, ideal for start-ups and companies initiating QMS implementation. - Outsourced legal manufacturing, providing a comprehensive solution for companies seeking full-service support and accelerated time to market.
LOK North America is a multi-disciplinary consulting firm committed to providing consulting services to emerging and small to mid-market companies and assist them in the developing process, design control, governmental approval, regulatory compliance, implementation of quality management system and after sales conformity for their medical devices and IVDs.
MD squared, with its inter-disciplinary team, provides the full circle of regulatory, clinical, technical and business support for Start-Ups, Scale-Ups, and SMEs to bring Medical Device Innovations to the market in time. Our collective knowledge and hands-on support enable our clients to gain actionable insights on interdependencies in their quest for meeting market and budgetary requirements.
MD101, with its large network of experts, assists medical device companies in developing and bringing products to market, accelerating time-to-market, and ensuring compliance with regulatory standards. MD101 provides mastery in a myriad of MDs support manufacturers in challenges such as quality assurance, regulatory affairs, clinical affairs, reimbursement strategy, or international business development.
MedTecXperts supports early-stage health tech companies establish their regulatory roadmap for their innovative and new medical devices on the European market, focussing on quality management, regulatory, market access (including clinical validation) and strategic business development. Working areas are medical devices, in vitro diagnostics, hardware, software (AI-based solutions) and the combination of these.
MedUniq is a Center of Competencies (Regulatory, Quality, Design & Engineering) dedicated to Medical Devices (Class I, IIa, IIb, III; Software & IA, Electromedical, Robotics, Mechanics & Biomaterials). Its team of technico-regulatory and quality consultants, with its network of qualified partners, offers support to Startups and SMEs, from the idea up to certification and market access.
Your EU regulatory partner for your medical devices and Health technologies. Our top EU experts will guide you through a customized soft-landing program and regulatory strategy for your technologies to be fully compliant with the European Union regulatory requirements, including clinical evaluation, software validation, AI & cybersecurity aspects, as well as notified body audit preparation
Swiss full-service CRO providing scientific, regulatory, clinical and quality assurance consulting support in the medical device, in-vitro diagnostics, and pharmaceutical areas. The company has an in-depth knowledge of the regulatory environment covering the development, certification and production of health products.
ProductLife Group supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access (pricing & reimbursement), vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.