Regulatory Thinking® for Industries
Our experience in the field of Regulatory Affairs and Certification Services for the Medtech and PPE (Personal Protective Equipment) industry and the certification of medical devices and Legal Manufacturers lies in the implementation of ISO 13485:2016 and ISO 9001:2015 processes (and in the transition from MDD to MDR) as well as in the implementation of risk management tools according to ISO 14971. The preparation of usability files according to ISO 62366 and of clinical evaluation and CERs following ISO 14155 and MEDDEV 2.7.1 / Rev.4.MDD, MDR, REGULATION (EU) 2016/425 (Personal Protective Equipment) as well as IMDRF (GHTF), NBMed, and MEDDEV Guidance Documents are familiar to us.
In the following, you get an overview of our offerings in the categories Education, Hands-on, and Auditing & Reviews.
Hands-on
STED: Technical Documentation ready to start Certification
To assist our clients during the certification process, we are defining the certification strategy and compiling the Technical Documentation.
➔ The lowest common, but most important denominator must be found in the Medical Device Regulation and can be described as follows: to always ensure the safety and high performance of medical technology by utilizing transparent evidence and a risk-based approach.
➔ We are giving hands-on in verification and validation, risk management, usability engineering, clinical evaluation, and PMS.
QMS: Quality Approved Managements Systems
Our team of experts and specialists consists of QARA Experts, External Auditors MedTech (Diplom SAQ), Certified Quality Auditors (European Organization for Quality / EOQ), and Lead Auditors (NB QS International Ltd.).
➔ We teach regulatory affairs and implement QM systems: Our guidelines and basic documents are used by industry and academia, e.g., the University of Zurich, University of Tübingen, German Society of Chemists, Medical Innovation Incubator, and many other organizations, institutions, and companies.
DiGA: Digital Healthcare Application
We assist you in the documentation, verification, and validation of your Healthcare App or your SaMD (software as a medical device). We guide you through the complete certification process including the negotiations with BfArM. Clinical Evaluation and the use of Real-World Data are also at the center of our DiGA services.
➔ Our clinical investigators, medical writers, and technical assessors assist in defining your clinical evaluation concept. Together with our clients and based on the functionality of the SaMD / Healthcare App we define safety, performance, and efficacy endpoints and anchor them in the clinical evaluation protocol.
➔ Statistical methods and drop-out calculations complete our services. We are auditing the CRO or the investigating healthcare unit according to related quality standards or GCP requirements.
➔ Having in mind the positive healthcare effect we monitoryour clinical evaluation, analyze the results obtained from the evaluation of the clinical study protocol, or evaluate your clinical data concept.
PoC: Point of Care Solution
The advances made in the last decade in manufacturing, optimizing, and delivering products used in the healthcare sector, directly to the patient, bring both benefits to the patient and some challenges to the manufacturer or user of these kinds of products.
Thus, the healthcare industry is in a transformative change: one of the key enablers of these changes is the proliferation of point-of-care (PoC) technologies, which can improve clinical outcomes and reduce costs by increasing access. PoC technologies have the potential to improve the management and treatment of various diseases and conditions, not only in resource-limited settings, where healthcare infrastructure is weak and access to quality and timely care is challenging.
PoC technologies are gaining ground in four areas in particular: (1) IVD, (2) SaMD, (3) surgery, specifically in orthopedics, CMF, and dental surgery, and (4) preparation of surgery.
While PoC solutions in the diagnostic or SaMD area make the products available to the patient 24/7 mostly in their home environment, PoC technologies in the orthopedic-surgical area bring the products directly to the user in the outpatient clinic or hospital.
➔ We assist you in defining and implementing a compelling regulatory strategy and certification pathway for your PoC device, always respecting the requirements given in MDR (EU) 2017/745.
Quality Seal: Quality Approved Technology (QAT)
Quality Controll certified Products (QCcP)
In some areas, especially with new technologies and applications, there are no common standards or regulations, but rather more standards derived from the manufacturer’s know-how. In other areas or exceptional and emergency cases, such as COVID-19 / Corona- SARS-CoV-2 Pandemy, for example, it is crucial to act fast and firm.
In such an emergency a manufacturer can not comply nor first perform all the prescribed formal test routines, lasting for months.
In these serious situations, the manufacturer must carry out quality assurance and must develop and market his products in such a way that safety and performance are guaranteed if the product is used within its intended use.
Design and Development – Regulatory Thinking®: My Regulatory Canvas.
To assist and guide developers at the beginning of the design process of their MedTech product, regulation, and certification experts together with certification bodies, regulatory experts @ ETH Zurich and MedDEV News developed a unique design and development tool: (c) My Regulatory Canvas 2021. My Regulatory Canvas respects the requirements stipulated in the Medical Device Regulation (EU) 2017/745 as well as in related Standards and Norms such as ISO 13485, ISO 14971, or IEC 62366 (DIN EN 62366-1).
Teaching
Regulations and legal texts such as standards and norms and/or the Medical Device Regulation (Regulation EU 2017/745) are not written to anticipate safety and performance requirements for future technologies but attempt to describe what is already established in a set of regulations. Innovative technologies are therefore not found in these texts and fall outside the scope.
To ensure that innovative technologies can still be used in the treatment of patients, it is particularly important to know exactly the applicable standards and laws. Only in this way it can be ensured that the “spirit” of the underlying regulation is adhered to, even in the case of new, innovative, and promising technologies, and that the requirements of the regulations and laws are also adapted and applied in their “original sense” to new technologies and methods.
We are teaching Regulatory Thinking® for QMS, Technical Documentation, Future Technologies, DiGA, AI, and PoC.
Certificate Courses in Regulatory Thinking®
“Our certificate courses start with regulatory affairs and product approval. We train “generalists” who have to answer questions from company- and product-approval in their start-up, KMU, academic or healthcare (hospital) environment.” (Dietmar Schaffarzyk, Lead Auditor and Technical Assessor)
Become an Expert and/or Coach in Regulatory Thinking® with these certificate courses that introduce you to the joined-up thinking that characterizes successful regulatory strategies and certification pathways. Each module is certified by the Certification Body QS International AG, is in itself a Quality Approved Certification Strategy (QACS), and concludes with a personal certificate.
Modules I & II are initially valid for 3 years and then can be renewed and re-certified repeatedly for another year. Module III must be re-certified every year. Module I enables the participant to act as a QARA specialist, in addition – module II can be one pre-requisite to act as a Person Responsible for Regulatory Compliance (PRRC), MDR Art. 15.
Our partners: Regulatory Experts @ ETH Zurich, 4C Accelerator, Stiftung für Medizininnovationen and Medical Innovations Incubator GmbH.
Module I: RT-Starter
Become a member of the community, learn “Regulatory Thinking®” and benefit from the network of experts who apply and teach this regulatory method.
In the first module, we convey the basic understanding and inter-relationships between a company’s business strategy and its regulatory strategy. We show the pivotal point, the intended use. Like a “spider in its web”, the intended use determines
the company’s orientation and policy, the advertising and marketing strategy, and the company’s external appearance.
We teach the correct handling and use of standards and introduce the 5 most important norms:
ISO 13485 / ISO 14971 / ISO 62366 ISO 62304 / ISO 60601.
Teaching method: Online and self-study
Teaching material: Scripts and RT templates
Module II: RT-Runner
You know the benefits of a QMS system. You are familiar with standards and norms. Now learn to adopt these methods and apply them within the scope of the MDR and IVDR. Successfully develop regulatory strategies and certification pathways.
In the second module, we show how everything is connected and what holds together the regulatory world on the inside. Of course, this is again the intended use and its verification and validation according to Regulation (EU) 2017/745.
The module teaches how a
a medical device project plan is developed and executed. You learn which processes must be set up and how the results of one process influence the results of another. The Medical Device Regulation (EU) 2017/745, and the Medical Device Regulation (EU) 2017/746 will guide us.
Teaching method: online and self-study
Teaching material: Scripts and RT templates
Module III: RT-Coach
Are you leading a team of regulatory experts? Do you want to implement Regulatory Thinking company-wide? Do you want to teach Regulatory Thinking yourself and push the boundaries of standards and norms?
In the third module, we break away from classical theory and the traditional/conventional understanding of standards and norms.
The focus now is on Regulatory Thinking®, applied to future technologies, artificial intelligence, and/or point of care solutions. We show how to navigate safely in the jungle and how to find new paths when no already “trodden path” exists.
The “machete in our hand” is safety, performance, and efficacy combined with a risk-based analytical approach. This approach is the “magic tool” of decision making, safety and performance indicators are the emergency lighting in the dark.
Teaching method: Online and self-study
Course material: Scripts and RT templates, regulatory canvas
Auditing & Reviews
Auditing QM- GCP-, GLP-, GMP-Systems
Our Lead Auditors
➔ review the QMS of your company and/or institution,
➔ investigate the QMS of your strategic partners and/or critical supplier,
➔ give you advice and help improving of QM-, GCP, GLP, and GMP-Systems.
Preparing, Conducting and Monitoring / CRO
Our Clinical Experts – GCP experts, medical writers, and clinical investigators, assist you in all your processes concerning the clinical evaluation of your product – implants, instruments, equipment, or SaMD.
➔ We offer you study preparation assistance, monitoring help and/or evaluation, auditing, and qualification work related to the medical centers in the scope of your clinical evaluation processes.
➔ Starting from scientific literature search and review, the definition of safety, performance, and efficacy endpoints writing the study protocol, on-boarding investigators or medical centers, power and drop-off calculations up to monitoring the study, analyzing the results, and compiling the clinical evaluation report – we are your partner.
Technical Assessment / Products and Technologies
Our Technical Assessors review your technical documentation or product files. We guide you in all verification and validation processes.
➔ We have experience in implant manufacturing (Class IIb / Class III), instruments and equipment (Class I / IIa / III), SaMD, and manufacturing processes for:
➔ Textile, Polymers, Metals. We are knowledgeable in extrusion technologies, molding and milling, 3D printing, and additive manufacturing as well as in various surface functionalization methods.