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Regulatory Compliance

Many medical device manufacturers don't realize that Notified Bodies can perform unannounced audits of your quality system. They can even audit your critical suppliers with very little notice. In this whitepaper, we answer your biggest questions about Notified Body audits and how to reduce the potential for an unannounced critical supplier audit, including: An overview of the role of Notified Bodies in European conformity What may be included in the Quality System Assessment How often to expect Unannounced Audits The importance of internal supplier audits You'll learn all this and more in...
Map of Europe where CE Mark is required
ヨーロッパ連合はCEマーキングを必要とする28カ国から成り立っております。ヨーロッパ連合の公式加盟国ではありませんが、3カ国(ノルウェー、アイスランド、リヒテンシュタイン)を追加したものが欧州経済地域(EEA)の協約国です。スイスはEUメンバーでもEEA協約国でもありませんが、医療機器指令を彼らの国法に移行しておりCEマーキングを必要としています。 弊社は御社医療機器をこれらヨーロッパ諸国内どこでも販売できるようにするための CEマーキング取得の 支援を提供致しております。
Map of Europe where CE Mark is required
Die europäische Union besteht aus 28 Ländern die eine CE-Kennzeichnung fordern. Drei zusätzliche Länder (Norwegen, Eisland, Lichtenstein), auch wenn nicht offizieller Teil der Europäischen Union, sind Unterzeichner des europäischen Wirtschaftsraumes (EEA). Die Schweiz ist weder ein EU-Mitglied noch ein Unterzeichner der EEA, aber die Medizinprodukte-Richtlinie ist in Ihrem nationalen Recht verankert und daher verlangt auch dieses Land die CE-Kennzeichnung. Wir unterstützen Sie beim Erlangen der CE-Kennzeichnung und ermöglichen den Verkauf Ihres Medizinproduktes in jedem dieser Länder. Sollten...
Map of Europe where CE Mark is required
L'Union européenne est composée de 28 pays qui exigent le marquage CE. Trois autres pays (Norvège, Islande et Liechtenstein), bien que ne faisant pas officiellement partie de l'Union européenne, sont signataires de l'Espace économique européen (EEE). La Suisse n'est pas membre de l'UE, ni signataire de l'EEE, mais a transposé les directives sur les dispositifs médicaux dans son droit national et ces pays exigent le marquage CE. Nous pouvons vous aider à obtenir le marquage CE afin de pouvoir vendre vos produits dans l'un ou plusieurs de ces pays européens.
Companies exporting their devices to international markets often underestimate the importance of translations. You may have an excellent product and a top distributor, but if your translations of device labels and IFU are poor, it can hurt sales and damage the reputation of your company. And, poor translations pose a liability risk if a misunderstanding leads to misuse of your device by a patient or user. In this article, we'll answer your biggest questions about requirements and best practices for translating device labeling and Instructions for Use (IFU). You will learn: What do European...
You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What do these changes mean and how will they affect your company? Europe's new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. In this 28-white paper, Emergo's experts in European regulations discuss what you can expect from the new MDR 2017/745 and how it will impact medical device...
Are you thinking about marketing your innovative device in Japan? If so, you should know that the Pharmaceuticals and Medical Devices Agency (PMDA) has specific clinical data requirements for certain devices. Determining the clinical data requirements for your device can be challenging. Failure to comply with these requirements can significantly delay the registration process and incur additional costs. In this white paper, we'll answer your biggest questions about clinical data requirements in Japan, including: When is clinical data required? How do we consult with the PMDA to determine...
Ready to sell your novel device in the United States? In a system based on predicate devices and substantial equivalence, marketing an innovative or novel device comes with some unique challenges. What do you do when your innovative device has no predicate? As the range of novel and innovative medical devices continues to grow, the challenge for both industry and the US FDA is to determine the best way to get these new devices to health care providers and patients as soon as possible, while ensuring safety and effectiveness. In this whitepaper, we discuss your options for bringing your novel...
Did the FDA request prospective human clinical data for your 510(k) submission? If so, it’s time to read up on regulatory requirements for quality assurance in human clinical studies. Failure to understand these requirements could lead to the FDA rejecting your clinical results, serious compliance actions, and a substantial waste of time and resources. This white paper provides insight into these requirements and breaks down the key elements of an effective, compliant clinical study. We’ll answer your biggest questions about quality assurance measures for one of the most significant (and...