{"id":15300,"date":"2026-11-13T08:33:20","date_gmt":"2026-11-13T07:33:20","guid":{"rendered":"https:\/\/blog.topsolid.com\/?p=15300"},"modified":"2026-11-13T16:11:21","modified_gmt":"2026-11-13T15:11:21","slug":"medical-machining-how-to-choose-cad-cam-software-for-manufacturing-medical-devices","status":"publish","type":"post","link":"https:\/\/blog.topsolid.com\/en\/medical-machining-how-to-choose-cad-cam-software-for-manufacturing-medical-devices\/","title":{"rendered":"Medical Machining: How to Choose CAD\/CAM Software for Manufacturing Medical Devices?"},"content":{"rendered":"

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Medical machining refers to the manufacture, through material removal, of prostheses, implants, instruments, and components for medical devices. CAD\/CAM software plays a unique role in this field: its use must be validated prior to implementation within an ISO 13485 quality management system, and it must allow users to determine, years later, which program version was used to machine a specific part. Here\u2019s how to translate these requirements into selection criteria.<\/span><\/p>\n

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What the Medical Industry Requires of Design and Manufacturing<\/strong><\/h2>\n

A regulatory framework that requires everything to be retained<\/b><\/h3>\n

Since May 26, 2021, Regulation (EU) 2017\/745<\/span><\/a> has governed the placing on the market of medical devices<\/span>. The manufacturer must keep the technical documentation available to the authorities for at least ten years <\/b>after the last device in question is placed on the market<\/span>, and for fifteen years in the case of an implantable device<\/b>.<\/span> The regulation also establishes a unique device identifier<\/span> (UDI)<\/span><\/a>, which is registered in the European Eudamed database.<\/span><\/span><\/p>\n

A precision machining subcontractor is not considered a manufacturer under the regulations. Nevertheless, its customers provide it with a significant portion of these requirements: drawing numbers, material certificates, and inspection records.<\/span><\/p>\n

A standard that also applies to your software<\/b><\/h3>\n

ISO 13485:2016<\/a> certification is not required by law, but clients in the industry very often require it<\/span>. The 2016 revision requires that software used in the quality system<\/span>, in production, and for measurement be validated <\/b><\/span>(paragraphs 4.1.6, 7.5.6, and 7.6)<\/span>: before initial use, and then after each modification, with an effort <\/span>commensurate with the risk. The LNE<\/a> also offers a training course on this requirement.<\/span><\/span><\/p>\n

One point deserves clarification, as it is often a source of confusion: validation focuses on how you use the software <\/b>within your organization. The standard governs a company\u2019s quality system, so there is no such thing as \u201cISO 13485-certified\u201d CAD\/CAM software. It is your responsibility to describe the intended use of the tool, assess the risk that its failures would pose to the part, test the corresponding scenarios, and maintain records. The ISO\/TR 80002-2 guide details this process.<\/span><\/span><\/p>\n

CAD\/CAM software that generates machine programs falls within this scope. Choosing it also means choosing what you\u2019ll have to validate\u2014and then revalidate.<\/span><\/p>\n

Demanding Parts, from Single Units to High-Volume Production<\/h3>\n

The medical field ranges from implants machined for a single patient to components produced by the thousands. The geometries are complex, the materials are expensive, and 5-axis machining centers\u2014such as MillTurn machines\u2014are now commonplace in these workshops.<\/p>\n

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Six Criteria for Choosing CAD\/CAM Software Suitable for Medical Machining<\/strong><\/h2>\n

1. Associative CAD and CAM<\/b><\/h3>\n

A customer modifies a tolerance. If the CAM system runs separately, the data must be reimported, reprogrammed, and rechecked\u2014with a real risk of machining the old dimension<\/b>. In the TopSolid\u2019Cam CAM software<\/a><\/span>, CAD and CAM are parametric and associative<\/b>: <\/span>the machining plan updates automatically as the model changes<\/span>, and part revisions are managed through the PDM.<\/span><\/span><\/p>\n

Demonstration: Change a dimension on a part that has already been programmed and see what updates automatically.<\/span><\/b><\/p>\n

2. An integrated PDM system that maintains a 15-year history<\/b><\/h3>\n

Fifteen years spans several generations of workstations, software versions, and employees. A shared file server is not designed to last that long. The right solution is a PDM system integrated into the design and manufacturing environment<\/b>, which tracks versions of each document and records who approved what.<\/span><\/span><\/p>\n

This is the approach taken by VERMON<\/a><\/span>, which designs and manufactures ultrasonic probes in Tours, primarily for use in ultrasound imaging. The company chose TopSolid, among other reasons, for its integrated PDM, which now manages tens of thousands of models.<\/span><\/span><\/p>\n

\u201cPDM is now a cornerstone of our design work.\u201d
Christophe Notard<\/b><\/span>, Program Management Officer at VERMON<\/span><\/span><\/p>\n

>>> Lire aussi \u2013<\/span>Sous-traitance multi-clients\u2009: l\u2019\u00e9pineuse question de la tra\u00e7abilit\u00e9<\/span><\/i><\/a><\/p>\n

3. Programming and simulation that match the complexity of the parts<\/b><\/h3>\n

Une pi\u00e8ce rebut\u00e9e dans un alliage de titane se paie en mati\u00e8re autant qu\u2019en temps machine. Le logiciel doit couvrir tous les proc\u00e9d\u00e9s d\u2019<\/span>usinage CNC<\/span><\/a>de l\u2019atelier et simuler la machine r\u00e9elle.<\/span><\/p>\n